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N/A XML0004

by GaleMed Xiamen Co., Ltd.

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 Number06923980114342 UDI-DI Date11 Sep 2024ListedStatusListed 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  • Withdrawn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

Generic Name
PEEP valve, single-use
Model / Reference
XML0004
Primary DI / UDI-DI
06923980114342
510(k) Number
FDA Product Code
BYE
GMDN Term
PEEP valve, single-use
Device Class
Class II
Regulation Number
868.5965
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: PEEP valve, single-use

Cleared under the same submission (K133957)

Other devices from GaleMed (Xiamen) Co., Ltd.

See all devices from GaleMed (Xiamen) Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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
  • Manufacturing Date: No