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), Coyote Brown w/CAT	01272CB-CAT	FDA UDI	Class I	Active
Emergency First Aid Kit, (EPMK-EFAK), Black	01427BK	FDA UDI	N	Active
TMM-FBT-SOF (Tactical Medical Module - Field Blood Transfusion-Spec Ops Forces)	4570	FDA UDI	Class II	Active
TMM- SL-M (Tactical Medical Module - Saline Lock - Military)	3831	FDA UDI	Class II	Active
Chinook LIFE Station, Intermediate, SWAT Tourniquet	06031	FDA UDI	Class I	Active
Home & Vehicle Kit, (EPMK) Hard Case, Yellow	01374HC	FDA UDI	N	Active
K9 Team Kit (TMK-K9T), Olive Drab Green	02178OD	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Refill w/SOFTT-W	01155REF	FDA UDI	Class I	Active
Chinook Chest Drain Valve	99671	FDA UDI	Class II	Unknown
Chinook LIFE Kit Basic, CAT Tourniquet	07010	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Olive Drab w/SOFTT-W	01239OD	FDA UDI	Class I	Active
My PAK, (Personal Aid Kit), Child, Black	02803BK	FDA UDI	N	Active
SOFTT-W and UTQ, Black w/Black Pull Tab	01392BKLE	FDA UDI	Class I	Active
Officer Response Kit, (LEMK-OR), Refill w/SOFTT-W, Contents Only	01152REF	FDA UDI	Class I	Active
IFAK Pouch Kit, Olive Drab w/CAT	01235OD-CAT	FDA UDI	Class I	Active
K9 TECC IFAK, Basic, Red	02321RD	FDA UDI	Class I	Active
Patrol Officer Kit (LEMK-PO), Red w/SOFTT-W	02171RD	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Black w/CAT	01278BK-CAT	FDA UDI	Class I	Active
TMM-CR (Tactical Medical Module - Cricothyroidotomy)	01364	FDA UDI	Class II	Active
C-A-T & UTQ, Coyote Brown	01393CB	FDA UDI	Class I	Active
RMT & UTQ, Olive Drab	01394OD	FDA UDI	Class I	Active
K9 Handler Kit (TMK-K9H), Coyote Brown	02177CB	FDA UDI	Class I	Active
Chinook MedsPAK	01399	FDA UDI	N	Active
SOFTT and UTQ (TMK-UTQ), Multi-Cam	01391MC	FDA UDI	Class I	Active
SOFTT and UTQ (TMK-UTQ), Olive Drab	01391OD	FDA UDI	Class I	Active
K9 TECC Kit, Advanced (TMK-K9A), Coyote Brown	02322CB	FDA UDI	Class I	Active
TMM - SL (Tactical Medical Module - Saline Lock)	1365	FDA UDI	Class II	Active
Medical Operator Kit, (TMK-MO), Multi-Cam w/SOFTT-W	01326MC	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Coyote Brown	01153CB	FDA UDI	Class I	Active
LEMM-K9HK, Advanced Kit	01458	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Multi-Cam w/CAT	01239MC-CAT	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Coyote Brown w/CAT	01155CB-CAT	FDA UDI	Class I	Active
TMM-BCR-Tactical Medical Module Bougie Assisted Cricothyrotomy	01438	FDA UDI	Class II	Active
Adventurer Kit	01424RD	FDA UDI	N	Active
Officer Response Kit, (LEMK-OR), Refill w/CAT, Contents Only	01152REF-CAT	FDA UDI	Class I	Active
Cravat/Triangular Bandage, Box 50	05001-50	FDA UDI	Class I	Active
TMK-MARCH Kit, Multi-Cam, W/CAT	01437MC-CAT	FDA UDI	Class I	Active
Chinook Bleeder PAK	01398	FDA UDI	Class I	Active
Chinook WoundPAK	01396	FDA UDI	Class I	Active
TMM - SL-S (Tactical Medical Module - Saline Lock - Standard)	3962	FDA UDI	Class II	Active
Medical Panel Insert Kit (TMK-MPI), Black w/SOFTT-W	01246BK	FDA UDI	Class I	Active
Wildland Firefighter Individual First Aid Kit, (WIFAK), Black	01429BK	FDA UDI	N	Active
Chinook LIFE Pack, Advanced, CAT Tourniquet	07022	FDA UDI	Class I	Active
Diagnostics Kit	02679	FDA UDI	N	Active
K9 TECC Special Operations Forces Kit (TMK-K9-SOF), Black	02323BK	FDA UDI	Class I	Active
My PAK, Adult (Personal Aid Kit), Black	02805BK	FDA UDI	N	Active
Gunshot Range Kit (LEMK-GSR), Red	02175RD	FDA UDI	Class I	Active
Traveler Kit (EPMK)	01423RD	FDA UDI	N	Active
Medical Pouch Kit (TMK-MP), Coyote Brown w/CAT	01269CB-CAT	FDA UDI	Class I	Active
Chinook LIFE Pack, Advanced, SWAT Tourniquet	06022	FDA UDI	Class I	Active

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