Medic Enhancement Set

Basic Information

• Brand Name: Medic Enhancement Set
• Primary DI: M6988250403010
• Version / Model: 01
• Catalog Number: 82-504-03
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-11
• Public Version: 4
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: 43503066-4f7d-4f2c-a455-a2af91d7d07f

Device Description

The Medic Enhancement Set is convenience kit with a capability improvement providing a combination of advanced tools for the management of massive hemorrhage, airway compromise, respiratory system insults and circulatory compromise. • The set is comprised of color coded MARCH protocol devices for rapid visual identification of the appropriate tool required under the MARCH protocol. • Each set is designed to augment or enhance first respondents treatment capacities. TMT-Tourniquet 2 ea Celox Rapid 2 ea iTClamp 1 ea Control-Cric 1 ea Sentinel Chest Seal 2 ea TALON IO Starter Set 1 ea Battle Bandage 2 ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
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	M6988250403010	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place