ADVANCED TRAUMA KIT

Basic Information

• Brand Name: ADVANCED TRAUMA KIT
• Primary DI: M689SHATKTMTSM010
• Version / Model: 01
• Catalog Number: SH-ATK-TMT-SM
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-27
• Public Version: 1
• Public Version Date: 2022-10-05
• Public Version Status: New
• Public Device Record Key: 8e78076d-4cba-4150-b761-ced5c3bc627e

Device Description

(1) TMT (Tactical Mechanical Tourniquet) (1) SWAT-T Orange (1) Celox B-Com (1) Dual Seal Occlusive Dressing (1) Thin H-Bandage (1) TACGAUZE (2) Pairs Vinyl Gloves (1) Trauma Shears 7.25” (1) Permanent Marker (1) Emergency Instructions

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
OHO	First Aid Kit Without Drug	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44057	General surgical procedure kit, medicated	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M689SHATKTMTSM010	HIBCC

Customer Contacts

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