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
My PAK, Adult (Personal Aid Kit), Red	02805RD	FDA UDI	N	Active
C-A-T & UTQ, Black	01393BK	FDA UDI	Class I	Active
Individual Operator Kit, (LEMK-IO), Olive Drab w/SOFTT-W	02172OD	FDA UDI	Class I	Active
Low Profile Insert (TMM-LPI)	01383MT	FDA UDI	Class I	Active
K9 Team Kit (TMK-K9T), Black	02178BK	FDA UDI	Class I	Active
Line Medic Kit, Coyote Brown w/CAT	01285CB-CAT	FDA UDI	N	Active
Medical Pouch Kit (TMK-MP), Refill, w/SOFTT-W, Contents Only	01269REF	FDA UDI	Class I	Active
Chinook LIFE Kit Basic, SOFTT-W Tourniquet	09010	FDA UDI	Class I	Active
Expedition Kit, (EPMK) Bag, Red	01390RD	FDA UDI	N	Active
Chinook LIFE Station, Intermediate, SAM XT Tourniquet	10031	FDA UDI	Class I	Active
Emergency First Aid Kit, (EPMK-EFAK), Olive Drab Green	01427OD	FDA UDI	N	Active
Chinook LIFE Pack, Basic, RMT Tourniquet <120 lbs	11020	FDA UDI	Class I	Active
Bleeding & CPR Basic Kit (EPMK)	01428RD	FDA UDI	Class I	Active
IFAK Pouch Kit, Refill w/CAT, Contents Only	01235REF-CAT	FDA UDI	Class I	Active
Project Lavoy Blood Kit	021274	FDA UDI	Class II	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Black w/SOFTT-W	01155BK	FDA UDI	Class I	Active
Army Combat Lifesaver Kit, Multi-Cam	01308MC	FDA UDI	Class I	Active
LEMK-GSR (Law Enforcement Medical Kit - Gunshot Range), Black w/CAT	02175BK-CAT	FDA UDI	Class I	Active
Chinook LIFE Station, Advanced, SAM XT Tourniquet	10032	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Multi-Cam w/CAT	01274MC-CAT	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Olive Drab w/CAT	01274OD-CAT	FDA UDI	Class I	Active
TMM-IV (Tactical Medical Module - Intravenous)	1352	FDA UDI	Class II	Active
K9 TECC Kit, Advanced (TMK-K9A), Refill, Contents Only	02322REF	FDA UDI	Class I	Active
K9 Team Kit (TMK-K9T), Multi-Cam	02178MC	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Coyote Brown w/SOFTT-W	01155CB	FDA UDI	Class I	Active
SOFTT-W and UTQ, Coyote Brown	01392CB	FDA UDI	Class I	Active
Mobile Aid Kit (EPMK-MAK), Advanced, Bag, Red	01377RD	FDA UDI	N	Active
My PAK, Child	02803RD	FDA UDI	N	Active
Care Under Fire Kit (TMK-CUF), Refill w/CAT, Contents Only	01272REF-CAT	FDA UDI	Class I	Active
Line Medic Kit, Black w/SOFTT-W	01285BK	FDA UDI	N	Active
TMK-CUF Kit, Advanced, Refill, CAT	01349REF-CAT	FDA UDI	Class I	Active
SOFTT-W and UTQ, Multi-Cam	01392MC	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Black w/SOFTT-W	01326BK	FDA UDI	Class I	Active
Patrol (LEMM-PATROL)	02210	FDA UDI	Class I	Active
Medical Pouch Kit (TMK-MP), Black w/CAT	01269BK-CAT	FDA UDI	Class I	Active
K9 TECC IFAK, Basic, Refill	02321REF	FDA UDI	Class I	Active
TMM - FBTK (Tactical Medical Module - Field Blood Transfusion Kit)	1370	FDA UDI	Class II	Active
TMK-MARCH Kit, Refill, W/SOFTTW	01437REF	FDA UDI	Class I	Active
Chinook Travel Suture Module	4611	FDA UDI	Class II	Active
Universal Tourniquet Pouch (TMK-UTQ), Black w/Black Pull Tab	01324BKLE	FDA UDI	N/A	Unknown
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Multi-Cam w/SOFTT-W	01155MC	FDA UDI	Class I	Active
Tactical Medical Module-Airway (TMM-AW)	01381	FDA UDI	Class I	Active
Adventurer Kit + Bleeding and CPR Basic	01424BC	FDA UDI	N	Active
Line Medic Kit, Black w/CAT	01285BK-CAT	FDA UDI	N	Active
RMT & UTQ, Black w/Black Pull Tab	01394BKLE	FDA UDI	Class I	Active
Combat Lifesaver Kit (TMK-CL), Refill w/CAT, Contents Only	01276REF	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Refill w/SOFTT-W, Contents Only	01274REF	FDA UDI	Class I	Active
Chinook LIFE Station, Advanced, RMT Tourniquet <120 lbs	11032	FDA UDI	Class I	Active
Universal Tourniquet Pouch (TMK-UTQ), Coyote Brown	01324CB	FDA UDI	N/A	Unknown
TMK-MARCH Kit, OD Green, W/SOFTTW	01437OD	FDA UDI	Class I	Active

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