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

Basic Information

• Brand Name: TMM-BCR-SOF, Tactical Medical Module- Bougie Assisted Cricothyrotomy-SOF
• Primary DI: 00856767008168
• Version / Model: 02923
• Catalog Number: 02923
• Company Name: Altitude Technologies Inc.
• Labeler DUNS: 621904622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-13
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 51ed8eae-40e7-4062-906d-ef6e6bf9da5c

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGP	Cricothyrotomy Kit	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45926	Cricothyrotomy kit, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856767008168	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]