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Game Ready* Ankle Heat Exchanger, Extra Large 120009312

by Avanos Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812120005472 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Game Ready* Ankle Heat Exchanger, Extra Large
Generic Name
Circulating-fluid localized thermal/compression therapy system wrap
Model / Ref / Catalog
120009312, 520340-04
Description
Right or Left Ankle Cold and Compression Heat Exchanger
Primary DI / UDI-DI
00812120005472
510(k) Number
FDA Product Code
IRP, ILO
GMDN Term
Circulating-fluid localized thermal/compression therapy system wrap
Device Class
Class II
Regulation Number
890.5650, 890.5720
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243572)

Show all (12)

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Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No