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Game Ready* Back Heat Exchanger 120009315

by Avanos Medical, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812120005502 UDI-DIDate31 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Game Ready* Back Heat Exchanger
Generic Name
Circulating-fluid localized thermal/compression therapy system wrap
Model / Ref / Catalog
120009315, 520500-04
Primary DI / UDI-DI
00812120005502
510(k) Number
FDA Product Code
ILO, IRP
GMDN Term
Circulating-fluid localized thermal/compression therapy system wrap
Device Class
Class II
Regulation Number
890.5720, 890.5650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243572)

Show all (12)

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

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