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Intermittent Catheter 010124

by Hangzhou Bever Medical Devices 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 23 Oct 2026

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 Number16948796206279 UDI-DI Date7 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Intermittent Catheter
Generic Name
Single-administration urethral drainage catheter
Model / Reference
010124
Primary DI / UDI-DI
16948796206279
510(k) Number
FDA Product Code
GBM
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 10 French
Shaft Length — 212 Millimeter

Related devices

Cleared under the same submission (K111405)

Show all (12)

Other devices from Hangzhou Bever Medical Devices Co., Ltd.

See all devices from Hangzhou Bever Medical Devices Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No