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
Emergency First Aid Kit, (EPMK-EFAK), Red	01427RD	FDA UDI	N	Active
Mobile Aid Kit (EPMK-MAK), Advanced, Hard Case, Yellow	01377HC	FDA UDI	N	Active
Covert Trauma Pouch Kit (TMK-CTP), Coyote Brown w/CAT	01328CB-CAT	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Coyote Brown w/SOFTT-W	01239CB	FDA UDI	Class I	Active
Chinook LIFE Station, Intermediate, RMT Tourniquet <120 lbs	11031	FDA UDI	Class I	Active
Army Combat Lifesaver Kit, Coyote Brown	01308CB	FDA UDI	Class I	Active
Chinook LIFE Pack, Basic, SWAT Tourniquet	06020	FDA UDI	Class I	Active
IFAK Pouch Kit, Olive Drab w/SOFTT-W	01235OD	FDA UDI	Class I	Active
Chinook LIFE Station, Advanced, SOFTT-W Tourniquet	09032	FDA UDI	Class I	Active
Officer Response Kit, (LEMK-OR), Black w/CAT	01152BK-CAT	FDA UDI	Class I	Active
Chinook LIFE Station, Advanced, CAT Tourniquet	07032	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Coyote Brown, SOFTT-W	01349CB	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Multi-Cam, CAT	01349MC-CAT	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Olive Drab w/CAT	01272OD-CAT	FDA UDI	Class I	Active
Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low Titer	021109	FDA UDI	Class II	Active
Medical Operator Kit, (TMK-MO), Coyote Brown w/CAT	01326CB-CAT	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Refill, SOFTT-W	01349REF	FDA UDI	Class I	Active
TMM - WC (Tactical Medical Module - Wound Closure)	1354	FDA UDI	Class II	Active
K9 Handler Kit (TMK-K9H), Multi-Cam	02177MC	FDA UDI	Class I	Active
LEMK-CTP (Law Enforcement Medical Kit - Covert Trauma Pouch), Black	01329BK	FDA UDI	Class I	Active
Officer Response Kit, (LEMK-OR), Coyote Brown w/SOFTT-W	01152CB	FDA UDI	Class I	Active
TMK-MARCH Kit, Multi-Cam, W/SOFTTW	01437MC	FDA UDI	Class I	Active
Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/CAT	01246CB-CAT	FDA UDI	Class I	Active
Chinook LIFE Kit Advanced, RMT Tourniquet <120 lbs	11012	FDA UDI	Class I	Active
Medical Panel Insert Kit (TMK-MPI), Black w/CAT	01246BK-CAT	FDA UDI	Class I	Active
Chinook LIFE Pack, Basic, CAT Tourniquet	07020	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Multi-Cam	01153MC	FDA UDI	Class I	Active
Gunshot Range Kit (LEMK-GSR), Refill, Contents Only	02175REF	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Black w/CAT	02171BK-CAT	FDA UDI	Class I	Active
Swat (lemm-Swat)	02211	FDA UDI	Class I	Active
Pressure Injury Prevention Kit	021316	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Refill, Contents Only	01153REF	FDA UDI	Class I	Active
LEMK-CTP, Covert Trauma Pouch, Coyote Brown	01329CB	FDA UDI	Class I	Active
Chinook LIFE Pack, Advanced, RMT Tourniquet <120 lbs	11022	FDA UDI	Class I	Active
TMM-K9-HK-SOF Tactical Medical Module K9 Under the Harness Trauma Kit	02934	FDA UDI	Class I	Active
Chinook LIFE Kit Intermediate, SOFTT-W Tourniquet	09011	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Olive Drab w/CAT	01239OD-CAT	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Multi-Cam w/CAT	01326MC-CAT	FDA UDI	Class I	Active
Chinook BVM Module	1373	FDA UDI	Class II	Active
LEMK-GSR (Law Enforcement Medical Kit - Gunshot Range), Refill w/CAT	02175REF-CAT	FDA UDI	Class I	Active
Covert Trauma Pouch Kit (TMK-CTP), Black w/SOFTT-W	01328BK	FDA UDI	Class I	Active
TMM-LTA (Tactical Medical Module-Low Titer Administration)	03955	FDA UDI	Class II	Active
K9 Handler Kit (TMK-K9H), Refill, Contents Only	02177REF	FDA UDI	Class I	Active
C-A-T & UTQ, Black w/Black Pull Tab	01393BKLE	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Olive Drab w/SOFTT-W	02171OD	FDA UDI	Class I	Active
Tactical Medical Module-Chest Wound (TMM-CW)	01353	FDA UDI	Class I	Active
Chinook LIFE Station, Basic, RMT Tourniquet <120 lbs	11030	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Black, w/SOFTT-W	01239BK	FDA UDI	Class I	Active
Chinook LIFE Pack, Advanced, SOFTT-W Tourniquet	09022	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Refill w/SOFTT-W, Contents Only	01278REF	FDA UDI	Class I	Active

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