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
TravelerPAK	01484	FDA UDI	N	Active
Individual Operator Kit, (TMK-IO), Black w/CAT	01274BK-CAT	FDA UDI	Class I	Active
IFAK Pouch Kit, Black w/CAT	01235BK-CAT	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Black w/SOFTT-W	01274BK	FDA UDI	Class I	Active
K9 Team Kit (TMK-K9T), Refill, Contents Only	02178REF	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Multi-Cam w/SOFTT-W	01274MC	FDA UDI	Class I	Active
Chinook LIFE Kit Intermediate, SWAT Tourniquet	06011	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Coyote Brown w/CAT	01278CB-CAT	FDA UDI	Class I	Active
K9 TECC Special Operations Forces Kit (TMK-K9-SOF), Refill, Contents Only	02323REF	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Black, w/CAT	01272BK-CAT	FDA UDI	Class I	Active
Chinook LIFE Pack, Intermediate, RMT Tourniquet <120 lbs	11021	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Black w/SOFTT-W	02171BK	FDA UDI	Class I	Active
IFAK Pouch Kit, Multi-Cam w/CAT	01235MC-CAT	FDA UDI	Class I	Active
TMK-MARCH Kit, OD Green, W/CAT	01437OD-CAT	FDA UDI	Class I	Active
Medical Panel Insert Kit (TMK-MPI), Refill w/SOFTT-W, Contents Only	01246REF	FDA UDI	Class I	Active
Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/SOFTT-W	01246CB	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Refill w/SOFTT-W, Contents Only	01272REF	FDA UDI	Class I	Active
C-A-T & UTQ, Olive Drab	01393OD	FDA UDI	Class I	Active
RMT & UTQ, Black	01394BK	FDA UDI	Class I	Active
Chinook LIFE Station, Basic, SAM XT Tourniquet	10030	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Coyote Brown w/CAT	01239CB-CAT	FDA UDI	Class I	Active
TMM-CR-SO (Tactical Medical Module - Cricothyroidotomy Special Operations)	04692	FDA UDI	Class II	Active
Individual Operator Kit, (TMK-IO), Refill w/CAT, Contents Only	01274REF-CAT	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Refill w/CAT, Contents Only	01239REF-CAT	FDA UDI	Class I	Active
K9 Team Kit (TMK-K9T), Coyote Brown	02178CB	FDA UDI	Class I	Active
K9 TECC IFAK, Basic, OD Green	02321OD	FDA UDI	Class I	Active
Officer Response Kit, (LEMK-OR), Coyote Brown w/CAT	01152CB-CAT	FDA UDI	Class I	Active
Universal Tourniquet Pouch (TMK-UTQ), Multi-Cam	01324MC	FDA UDI	N/A	Unknown
Medic Kit (TMK-ME), Refill w/CAT, Contents Only	01278REF-CAT	FDA UDI	Class I	Active
Line Medic Refill w/CAT Contents Only	01285REF-CAT	FDA UDI	N	Active
Individual Operator Kit, (TMK-IO), Coyote Brown w/CAT	01274CB-CAT	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Olive Drab w/CAT	01326OD-CAT	FDA UDI	Class I	Active
TMM - SL-SO (Tactical Medical Module - Saline Lock - Special Operations)	4693	FDA UDI	Class II	Active
K9 TECC IFAK, Basic, Black	02321BK	FDA UDI	Class I	Active
Chinook LIFE Station, Basic, CAT Tourniquet	07030	FDA UDI	Class I	Active
Hypothermia Management Kit, (TMM-HMK)	01361	FDA UDI	Class I	Active
TMM-PPE, Basic	01456	FDA UDI	Class I	Active
Chinook ToolPAK	01397	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Olive Drab Green w/CAT	01278OD-CAT	FDA UDI	Class I	Active
Chinook LIFE Kit Advanced, SOFTT-W Tourniquet	09012	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Black w/CAT	01239BK-CAT	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Multi-Cam w/SOFTT-W	01239MC	FDA UDI	Class I	Active
Covert Trauma Pouch Kit (TMK-CTP), Black w/CAT	01328BK-CAT	FDA UDI	Class I	Active
Universal Tourniquet Pouch (TMK-UTQ), Black w/Red Pull Tab	01324BK	FDA UDI	N/A	Unknown
TMM-PPE, Advanced	01457	FDA UDI	Class I	Active
SOFTT-W and UTQ, Black	01392BK	FDA UDI	Class I	Active
TMM - NG/OG (Tactical Medical Module - Nasogastric/Orogastric)	5007	FDA UDI	Class II	Active
Chinook BurnPAK	01402	FDA UDI	Class I	Active
RMT & UTQ, Coyote Brown	01394CB	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Olive Drab w/CAT	01155OD-CAT	FDA UDI	Class I	Active

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