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Cocoon CLM 0127P

by Care Essentials Pty Ltd

Listed FDA GUDID listing, no authorization on record

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 Number09332017002991 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: 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  • Withdrawn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
Cocoon
Generic Name
External circulating-air core temperature regulation system pad, single-use
Model / Ref / Catalog
CLM 0127P
Primary DI / UDI-DI
09332017002991
FDA Product Code
DWJ
GMDN Term
External circulating-air core temperature regulation system pad, single-use
Device Class
Class II
Regulation Number
870.5900
GUDID distribution status
In Commercial Distribution

Other devices from Care Essentials Pty Ltd

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No