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MEDICOLOR JoyMask Cool 20S

by Shenzhen Sany Pioneer Technology Co., Ltd

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850088881059 UDI-DI Date14 Jul 2026ListedStatusListed 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  • Withdrawn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
Medicolor
Generic Name
CPAP/BPAP face mask, reusable
Model / Reference
JoyMask Cool 20S
Primary DI / UDI-DI
00850088881059
FDA Product Code
BZD
GMDN Term
CPAP/BPAP face mask, reusable
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
Not in Commercial Distribution

Other devices from Shenzhen Sany Pioneer Technology Co., Ltd

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Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No