FDA.reportPublic FDA data

TMM-BCR-SOF, Tactical Medical Module- Bougie Assisted Cricothyrotomy-SOF

Primary DI
00856767008168
Brand
TMM-BCR-SOF, Tactical Medical Module- Bougie Assisted Cricothyrotomy-SOF
Company
Altitude Technologies Inc.
Model
02923
Catalog number
02923
Device description
The TMM-BCR-SOF contains the necessary items to establish a surgical airway with a Bougie tube introducer when other methods are unsuccessful, as requested by the U.S. Millitary.
Published
2020-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGPCricothyrotomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856767008168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856767008168008567670081688567670081680856767008168

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-766-1365sales@chinookmed.com

Regulatory Flags#

DUNS number
621904622
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00850062467170GAP IFAK, RG0213170213172026-01-27
00850062467187GAP IFAK, BK021317BK021317BK2026-01-27
00850062467194GAP IFAK, MC021317MC021317MC2026-01-27
00850062467200GAP IFAK Refill021317REF021317REF2026-01-27
00850062467156Medic Kit (TMK-ME), Black w/SOFTT-W01678BK01678BK2026-01-14
00850062467163Medic Kit (TMK-ME), Black w/CAT01678BK-CAT01678BK-CAT2026-01-14
00850018892834My PAK, Adult (Personal Aid Kit), Black02805BK02805BK2020-06-10
00856767008359My PAK, Adult (Personal Aid Kit), Red02805RD02805RD2020-05-19
00850018892858My PAK, (Personal Aid Kit), Child, Black02803BK02803BK2020-08-11
00856767008366My PAK, Child02803RD02803RD2020-05-19
00850062467149Corpsman Assault Pack Restock0212022025-08-07
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)0215552025-08-04
00850062467040GFAK021317PA2024-10-17
00850062467033TMM-FC050062024-10-03
00863970000469TMM-FC (Tactical Medical Module - Foley Catheter)50062018-05-15
00850062467026Pressure Injury Prevention Kit0213162024-09-18
00850062467019Project Lavoy Blood Kit0212742024-06-19
00850018892872Chinook IDPA Individual Direct Pressure Adjunct053232023-10-30
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138586NARNORTH AMERICAN RESCUE, LLCOGP2026-04-22
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50198956284683CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
00850063404433ForwardSynchronis Medical, LLCOGP2025-12-31
00850063404440ForwardSynchronis Medical, LLCOGP2025-12-31
M689HHECT01040Emergency Cric KitSafeguard US Operating, LLCOGP2025-12-19
10198956257818CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
50198956257816CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
00850070635066Endotracheal KitNar Medical Depot, LLCOGP2025-12-01
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)Altitude Technologies Inc.OGP2025-08-04
00860009615564Endotracheal KitNar Medical Depot, LLCOGP2025-07-21
10198956054233CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
50198956054231CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
00842209135066NARNORTH AMERICAN RESCUE, LLCOGP2025-05-21
00842209133789NARNORTH AMERICAN RESCUE, LLCOGP2024-12-18
00842209130597NARNORTH AMERICAN RESCUE, LLCOGP2024-03-13
00842209130337NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209130368NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209129690TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2024-01-17
00842209129249TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2023-11-16
00842209128327NARNORTH AMERICAN RESCUE, LLCOGP2023-08-24
00842209127658NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127665NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127481NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209127580NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209126576NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
00842209126590NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
10197106110959CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
50197106110957CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
M689HHSCK01EA020Simplified Cricothyrotomy KitSafeguard US Operating, LLCOGP2022-08-10