Question 1

What types of medical devices does Altitude Technologies Inc. manufacture?

Accepted Answer

Altitude Technologies Inc. specializes in emergency medical and trauma response devices. Their portfolio includes first aid kits (both non-medicated and medicated), blood transfusion sets, peripheral vascular and intravenous catheterization support tools, pneumothorax catheter insertion sets, airway needles, and cricothyrotomy kits. These products are designed primarily for tactical, field, and pre-hospital medical use, ensuring readiness for critical situations.

Question 2

Where is Altitude Technologies Inc. based, and how does that affect its regulatory standing?

Accepted Answer

Altitude Technologies Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database lists their products, which helps ensure traceability and compliance with U.S. medical device requirements. The classification of their devices (Class I, Class II, or non-classifiable) is determined by the FDA based on risk and intended use.

Question 3

Which regulatory registries or databases list Altitude Technologies Inc.’s devices?

Accepted Answer

Altitude Technologies Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring transparency in the supply chain and aiding in regulatory oversight. This listing helps healthcare providers, regulators, and other stakeholders verify the identity and compliance status of the company’s products.

Question 4

How are Altitude Technologies Inc.’s devices classified by the FDA?

Accepted Answer

Altitude Technologies Inc.’s devices are classified under the FDA’s regulatory framework as either Class I, Class II, or non-classifiable (N). The classification depends on the risk associated with the device’s use and its intended purpose. For example, single-use first aid kits like their Patrol Officer Kit or MiniFAK are typically lower-risk and may fall under Class I or II, while specialized tools like cricothyrotomy kits or catheterization support kits could carry higher regulatory scrutiny due to their critical medical applications.

Question 5

What distinguishes Altitude Technologies Inc.’s device portfolio from other manufacturers?

Accepted Answer

Altitude Technologies Inc. focuses on trauma response and field medical readiness, particularly for tactical and pre-hospital use. Their devices are designed for portability and single-use scenarios, such as their first aid kits (e.g., Combat Lifesaver Kit or Expedition Kit) and specialized tools like pneumothorax drainage systems or airway needles. This emphasis on emergency preparedness and operational efficiency sets their portfolio apart, catering to military, law enforcement, and wilderness or disaster response applications.

Device	Model / Reference	Registries	Class	Status
Care Under Fire Kit (TMK-CUF), Multi-Cam w/CAT	01272MC-CAT	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Black w/Black Pull Tab	01153BKLE	FDA UDI	Class I	Active
IV Start Kit w/Catheter, 18Ga	020210	FDA UDI	Class II	Active
Vaccine Administration Kit, Individual	04654	FDA UDI	Class II	Unknown
1st Responder Kit (EPMK-1st Responder Kit)	01425RD	FDA UDI	N	Active
K9 Handler Kit (TMK-K9H), Olive Drab	02177OD	FDA UDI	Class I	Active
Whole Blood Collection and Transfusion Kit	3425	FDA UDI	Class II	Active
TMK-CUF Kit, Advanced, OD Green, CAT	01349OD-CAT	FDA UDI	Class I	Active
IFAK Insert Kit, Black	01237BK	FDA UDI	Class I	Active
Universal Tourniquet Pouch (TMK-UTQ), OD Green	01324OD	FDA UDI	N/A	Unknown
Individual Operator Kit, (LEMK-IO), Black w/SOFTT-W	02172BK	FDA UDI	Class I	Active
Bleeding & CPR Advanced Kit (EPMK)	01426RD	FDA UDI	Class I	Active
TMM-ETI (Tactical Medical Module - Endotracheal Intubation)	01380	FDA UDI	Class II	Active
LEMK-GSR (Law Enforcement Medical Kit - Gunshot Range), Red w/CAT	02175RD-CAT	FDA UDI	Class I	Active
Chinook LIFE Kit Basic, SWAT Tourniquet	06010	FDA UDI	Class I	Active
Traveler Kit (EPMK), Bleeding and CPR Basic	01423BC	FDA UDI	N	Active
Chinook LIFE Pack, Intermediate, SOFTT-W Tourniquet	09021	FDA UDI	Class I	Active
Medical Pouch Kit (TMK-MP), Refill, w/CAT, Contents Only	01269REF-CAT	FDA UDI	Class I	Active
Mobile Aid Kit (MAK), Bag, Red	01376RD	FDA UDI	N	Active
Individual Operator Kit, (LEMK-IO), Olive Drab w/CAT	02172OD-CAT	FDA UDI	Class I	Active
K9 TECC Special Operations Forces Kit (TMK-K9-SOF), Olive Drab Green	02323OD	FDA UDI	Class I	Active
Line Medic Kit, Olive Drab w/SOFTT-W	01285OD	FDA UDI	N	Active
Home & Vehicle Kit, (EPMK) Bag, Red	01374RD	FDA UDI	N	Active
Line Medic Refill, Contents Only	01285REF	FDA UDI	N	Active
Medic Kit (TMK-ME), Multi-Cam w/CAT	01278MC-CAT	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Multi-Cam, SOFTT-W	01349MC	FDA UDI	Class I	Active
Chinook Travel Syringe Module	04691	FDA UDI	Class I	Active
LEMK-CTP, Covert Trauma Pouch, Refill, Contents Only	01329REF	FDA UDI	Class I	Active
K9 TECC Special Operations Forces Kit (TMK-K9-SOF), Multi-Cam	02323MC	FDA UDI	Class I	Active
Chinook LIFE Kit Advanced, C.A.T. Tourniquet	07012	FDA UDI	Class I	Active
TMM-LTC (Tactical Medical Module - Low Titer Collection)	3954	FDA UDI	Class II	Active
Medic Kit (TMK-ME), Olive Drab Green w/SOFTT-W	01278OD	FDA UDI	Class I	Active
Covert Trauma Pouch Kit (TMK-CTP), Refill w/SOFTT-W, Contents Only	01328REF	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Black, CAT	01349BK-CAT	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Olive Drab w/CAT	02171OD-CAT	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, OD Green, SOFTT-W	01349OD	FDA UDI	Class I	Active
Chinook LIFE Kit Advanced, SAM XT Tourniquet	10012	FDA UDI	Class I	Active
Medical Panel Insert Kit (TMK-MPI), Refill w/CAT, Contents Only	01246REF-CAT	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Coyote Brown w/SOFTT-W	01272CB	FDA UDI	Class I	Active
Officer Response Kit, (LEMK-OR), Black w/SOFTT-W	01152BK	FDA UDI	Class I	Active
TMK-MARCH Kit, Black W/SOFTTW	01437BK	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Refill w/SOFTT-W, Contents Only	01326REF	FDA UDI	Class I	Active
Chinook Suture/Syringe Module	1210	FDA UDI	Class II	Active
K9 TECC Kit, Advanced (TMK-K9A), Multi-Cam	02322MC	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Black, w/SOFTT-W	01272BK	FDA UDI	Class I	Active
Combat Lifesaver Kit (TMK-CL), Black w/CAT	01276BK	FDA UDI	Class I	Active
Intravenous-Intraosseous Kit (TMK-IV/IO), Black	01323BK	FDA UDI	Class II	Active
Chinook LIFE Pack, Advanced, SAM XT Tourniquet	10022	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Refill w/CAT, Contents Only	01326REF-CAT	FDA UDI	Class I	Active
Chinook LIFE Kit Intermediate, SAM XT Tourniquet	10011	FDA UDI	Class I	Active

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