EM

Basic Information

• Brand Name: EM
• Primary DI: 00026072025543
• Version / Model: L720
• Company Name: Allied Medical, LLC
• Labeler DUNS: 119066872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-11
• Public Version: 2
• Public Version Date: 2025-10-13
• Public Version Status: Update
• Public Device Record Key: 57c6ef41-c5a7-402d-a2b8-1f2998d8ade4

Device Description

HALFBACK EXTRACT VEST W/COLOR

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
FMR	Device, Transfer, Patient, Manual	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36294	Chest impact protector	A device designed to be worn over the front of the chest to provide a padded garment to protect the chest from damage caused by falls against objects which would cause bruising and/or damage to the ribs. It is typically made from soft padded materials in the form of a vest and is held in place with bands or straps over the shoulders and around the back. It is typically used by persons who have tendencies for falls (e.g., due to loss of control of their motor system) and are prone to chest injury. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00026072025543	GS1