First Aid Only

Basic Information

• Brand Name: First Aid Only
• Primary DI: 00092265508490
• Version / Model: M5084
• Catalog Number: M5084
• Company Name: Acme United Corporation
• Labeler DUNS: 001180207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-21
• Public Version: 1
• Public Version Date: 2022-01-31
• Public Version Status: New
• Public Device Record Key: 39f25580-1886-4140-887d-89665751b770

Device Description

Splint Inflatable - Half arm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	878.3900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32302	Inflatable extremity splint	A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00092265508490	GS1

Customer Contacts

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