IMAK Compression

Basic Information

• Brand Name: IMAK Compression
• Primary DI: 00649833201729
• Version / Model: A20172
• Company Name: BROWNMED, INC.
• Labeler DUNS: 091999771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 1
• Public Version Date: 2020-09-01
• Public Version Status: New
• Public Device Record Key: 97947727-e25b-4f9f-b8ae-c2670f370e08

Device Description

Arthritis Glove

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: Yes
• 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16500	Compression/pressure glove	A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00649833201729	GS1