{"id":3262,"date":"2025-09-17T13:00:50","date_gmt":"2025-09-17T13:00:50","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3262"},"modified":"2025-09-17T13:00:50","modified_gmt":"2025-09-17T13:00:50","slug":"anesthesia-and-oxygen-delivery-masks-classification-and-grouping-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/anesthesia-and-oxygen-delivery-masks-classification-and-grouping-in-colombia\/","title":{"rendered":"Anesthesia and Oxygen Delivery Masks: Classification and Grouping in Colombia"},"content":{"rendered":"<p><span data-contrast=\"auto\">Face masks are vital medical devices used extensively in Colombian healthcare settings, from emergency rooms to operating theaters. Their primary role is to deliver precise mixtures of gases such as oxygen, air, or anesthetic agents, tailored to patient needs.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Given the wide range of mask types and their specialized functions, understanding how INVIMA classifies and regulates these devices is essential for companies seeking <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/ultimate-guide-for-regulatory-affairs-in-colombia\/#register\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">sanitary registration and successful market entry in Colombia.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">In this article, we will explore the different categories of face masks available and how they are classified under INVIMA\u2019s regulatory framework.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Types of Masks<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Medical face masks are generally divided into two primary categories based on their clinical application:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1428,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Anesthesia Masks. <\/span><\/b><span data-contrast=\"auto\">Used during surgical procedures, these masks deliver anesthetic gases to patients. Their classification typically considers:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Patient age group<\/span><\/b><span data-contrast=\"auto\">: Neonatal, infant, pediatric, and adult<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Design<\/span><\/b><span data-contrast=\"auto\">: Standard or anatomical<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Material and features<\/span><\/b><span data-contrast=\"auto\">: options include clear, inflatable, specialty designs, and materials such as silicone or PVC<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1428,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Oxygen Delivery Masks. <\/span><\/b><span data-contrast=\"auto\">Th<\/span><span data-contrast=\"auto\">ese masks are intended to provide supplemental oxygen and are further classified by their delivery method:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Simple masks<\/span><\/b><span data-contrast=\"auto\">: Provide low-flow oxygen without precise concentration control<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Venturi masks<\/span><\/b><span data-contrast=\"auto\">: Enable accurate regulation of oxygen concentration<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Non-rebreathing masks<\/span><\/b><span data-contrast=\"auto\">: Deliver high oxygen concentrations while preventing re-inhalation of exhaled gases<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:2148,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Aerosol masks<\/span><\/b><span data-contrast=\"auto\">: Administer oxygen in mist form, often used with nebulizers<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:2148,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Additionally, <\/span><b><span data-contrast=\"auto\">tracheostomy masks, <\/span><\/b><span data-contrast=\"auto\">though related to oxygen therapy, are typically categorized separately due to their specialized structure and use in patients with tracheostomy tubes.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/device-classification-and-device-grouping-colombia\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Classification and Grouping in Colombia<\/span><\/b><\/a><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Colombia, anesthesia and oxygen delivery masks are classified as <\/span><b><span data-contrast=\"auto\">Class IIa medical <\/span><\/b><span data-contrast=\"auto\">devices.\u00a0 This classification reflects their non-invasive nature and the duration of their contact with patients, which can range from a few minutes to several days.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">When preparing for sanitary registration, it is important to align with INVIMA\u2019s expectations. The following strategy is suggested:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Anesthesia masks:<\/span><\/b><span data-contrast=\"auto\"> Models that differ only in patient age group (e.g., neonatal, pediatric, adult), shape (standard vs. anatomical), or secondary features (e.g., clear, inflatable, silicone, PVC) may be grouped under a single registration, provided they share the same base materials and technological principles.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Oxygen delivery masks:<\/span><\/b><span data-contrast=\"auto\"> Due to significant variations in design, operating mechanisms, materials, and intended use, these masks are typically registered individually. However, in certain cases, a technical justification may support grouping similar models under one registration.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Tracheostomy masks:<\/span><\/b><span data-contrast=\"auto\"> These must be registered separately due to their distinct intended use and technology.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Additional Considerations<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Some anesthesia or oxygen delivery masks are designed to be used as part of anesthesia machines or mechanical ventilators. While these machines are classified as medical equipment, the masks themselves, especially single-use ones, must be registered separately and are not considered accessories.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Classifying and grouping anesthesia and oxygen delivery masks for INVIMA registration in Colombia can be complex. While general principles provide a foundation, each product requires a tailored evaluation to ensure full compliance with national standards.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For expert support in streamlining your registration strategy and accelerating market access, reach out to us at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/b><\/a><span data-contrast=\"auto\">. Our team is ready to guide you through every step of the process with precision and local insight.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Face masks are vital medical devices used extensively in Colombian healthcare settings, from emergency rooms to operating theaters. Their primary role is to deliver precise mixtures of gases such as oxygen, air, or anesthetic agents, tailored to patient needs.\u00a0 &nbsp; Given the wide range of mask types and their specialized functions, understanding how INVIMA classifies [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3263,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,396],"tags":[],"class_list":["post-3262","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-colombia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Anesthesia and Oxygen Masks: Classification Colombia - Veraque Colombia<\/title>\n<meta name=\"description\" content=\"Explore examples of anesthesia and oxygen masks and understand their 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