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HemoCool Gel-Pak 8100

by Biosynergy, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM74481000 UDI-DIDate10 Jan 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HemoCool Gel-Pak
Generic Name
Musculoskeletal hot/cold therapy pack, reusable
Model / Ref / Catalog
8100
Primary DI / UDI-DI
M74481000
FDA Product Code
KSE
GMDN Term
Musculoskeletal hot/cold therapy pack, reusable
Device Class
Class II
Regulation Number
864.9700
GUDID distribution status
Not in Commercial Distribution

Other devices from Biosynergy, Inc.

Properties

  • Premarket Exempt

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No