Medical Trauma Kit Individual Trauma Kit OTC

Basic Information

• Brand Name: Medical Trauma Kit Individual Trauma Kit OTC
• Primary DI: M689SDRVSIPOTC010
• Version / Model: 1
• Catalog Number: SDR-VSIP-OTC
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-03
• Public Version: 1
• Public Version Date: 2022-06-13
• Public Version Status: New
• Public Device Record Key: ca53d7f2-36d1-4eb1-8977-36fef1d53b37
• Distribution End Date: 9999-06-02

Device Description

1 - TMT-Tourniquet 1 - Celox RAPID B-Con 1 - Positional Airway Card 2 - Sentinel Chest Seal 1 - Emergency Bandage 1 - Blizzard IFAK Blanket 2 - Exam Gloves 1 - Quick Reference Guide

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M689SDRVSIPOTC010	HIBCC