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Freedom Wave II

by Freedom Medical, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856698004185 UDI-DIDate27 Sep 2017ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 21 Oct 2026.

Specification

GUDID

Generic Name
Low-air-loss bed
Model / Reference
Wave II
Primary DI / UDI-DI
00856698004185
FDA Product Code
FNM
GMDN Term
Low-air-loss bed
Device Class
Class II
Regulation Number
880.5550
Commercial Distribution
In Commercial Distribution

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Expiration Date: No