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
IFAK Insert Kit, Coyote Brown	01237CB	FDA UDI	Class I	Active
Covert Trauma Pouch Kit (TMK-CTP), Refill w/CAT, Contents Only	01328REF-CAT	FDA UDI	Class I	Active
Medical Pouch Kit (TMK-MP), Black, w/SOFTT-W	01269BK	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Black w/Red Pull Tab	01153BK	FDA UDI	Class I	Active
Tmm-Edc-L	021230	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Multi-Cam w/SOFTT-W	01278MC	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Red w/CAT	02171RD-CAT	FDA UDI	Class I	Active
TMM-BCR-SOF, Tactical Medical Module- Bougie Assisted Cricothyrotomy-SOF	02923	FDA UDI	Class II	Active
Chinook LIFE Pack, Basic, SOFTT-W Tourniquet	09020	FDA UDI	Class I	Active
IFAK Insert Kit, Refill, Contents Only	01237REF	FDA UDI	Class I	Active
Line Medic Kit, Olive Drab w/CAT	01285OD-CAT	FDA UDI	N	Active
Intravenous-Intraosseous Kit (TMK-IV/IO), Refill, Contents Only	01323REF	FDA UDI	Class II	Active
Corpsman Assault Pack Restock	021202	FDA UDI	N	Active
Individual Operator Kit, (LEMK-IO), Refill w/SOFTT-W, Contents Only	02172REF	FDA UDI	Class I	Active
TMM-CT (Tactical Medical Module-Chest Tube)	01378	FDA UDI	Class I	Active
TMM-FC (Tactical Medical Module - Foley Catheter)	5006	FDA UDI	Class II	Unknown
K9 Handler Kit (TMK-K9H), Black	02177BK	FDA UDI	Class I	Active
Low Profile Insert (LEMM-LPI)	01383LE	FDA UDI	Class I	Active
TMK-CUF Kit, Advanced, Black, SOFTT-W	01349BK	FDA UDI	Class I	Active
IFAK Pouch Kit, Refill w/SOFTT-W, Contents Only	01235REF	FDA UDI	Class I	Active
Gfak	021317PA	FDA UDI	Class I	Active
TMK-MARCH Kit, Coyote Brown, W/CAT	01437CB-CAT	FDA UDI	Class I	Active
IFAK Pouch Kit, Coyote Brown w/CAT	01235CB-CAT	FDA UDI	Class I	Active
Medical Pouch Kit (TMK-MP), Coyote Brown, w/SOFTT-W	01269CB	FDA UDI	Class I	Active
Covert Trauma Pouch Kit (TMK-CTP), Coyote Brown w/SOFTT-W	01328CB	FDA UDI	Class I	Active
Combat Lifesaver Kit (TMK-CL), Coyote Brown w/CAT	01276CB	FDA UDI	Class I	Active
SOFTT and UTQ (TMK-UTQ), Black	01391BK	FDA UDI	Class I	Active
TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)	04135	FDA UDI	Class II	Active
IFAK Pouch Kit, Coyote Brown w/SOFTT-W	01235CB	FDA UDI	Class I	Active
TMM-NPA Naso Airway Module	02118	FDA UDI	Class I	Unknown
Medic (LEMM-MEDIC)	02212	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Coyote Brown w/SOFTT-W	01278CB	FDA UDI	Class I	Active
Chinook LIFE Station, Advanced, SWAT Tourniquet	06032	FDA UDI	Class I	Active
Chinook LIFE Station, Basic, SOFTT-W Tourniquet	09030	FDA UDI	Class I	Active
TMK-MARCH Kit, Black W/CAT	01437BK-CAT	FDA UDI	Class I	Active
TMK-MARCH Kit, Refill, W/CAT	01437REF-CAT	FDA UDI	Class I	Active
IFAK Pouch Kit, Black w/SOFTT-W	01235BK	FDA UDI	Class I	Active
Chinook Medication Module	01332	FDA UDI	N	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Multi-Cam w/CAT	01155MC-CAT	FDA UDI	Class I	Active
Chinook 6PAK	01403	FDA UDI	N	Active
Medical Operator Kit, (TMK-MO), Ollive Drab w/SOFTT-W	01326OD	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Refill w/CAT, Contents Only	02171REF-CAT	FDA UDI	Class I	Active
Individual Operator Kit, (LEMK-IO), Black w/CAT	02172BK-CAT	FDA UDI	Class I	Active
Vaccine Administration Kit, Facility	04656	FDA UDI	Class II	Active
TMM-SI-SOF, Surgical Intervention-Special Operations Forces	01432	FDA UDI	Class II	Active
K9 TECC Special Operations Forces Kit (TMK-K9-SOF), Coyote Brown	02323CB	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Multi-Cam w/SOFTT-W	01272MC	FDA UDI	Class I	Active
Chinook LIFE Station, Intermediate, CAT Tourniquet	07031	FDA UDI	Class I	Active
FS EZ IO Kit Manual 6PK	021171	FDA UDI	Class II	Active
Chinook LIFE Station, Intermediate, SOFTT-W Tourniquet	09031	FDA UDI	Class I	Active

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