Elite Mylar Blanket

Basic Information

• Brand Name: Elite Mylar Blanket
• Primary DI: 00816703023228
• Version / Model: ELITE-B100
• Catalog Number: Not Applicable
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-20
• Public Version: 3
• Public Version Date: 2022-11-29
• Public Version Status: Update
• Public Device Record Key: dcc1532b-9b41-4307-9455-a36e16c88c59

Device Description

Elite Mylar Blanket / Elite First Aid Part Number: 700

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10416	Rescue blanket, reusable	A large sheet of material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00816703023235	GS1	Case	200	In Commercial Distribution
Primary	00816703023228	GS1