Skip to content

Disposable intermittent catheter (TPU Catheter) H09-08M

by Chengdu Daxan Innovative Medical Tech. 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 Number06942214120775 UDI-DI Date12 Jun 2026ListedStatusListed 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  • Withdrawn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

Trade Name
Disposable intermittent catheter (TPU Catheter)
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Model / Reference
H09-08M
Primary DI / UDI-DI
06942214120775
510(k) Number
FDA Product Code
EZD
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243175)

Show all (12)

Other devices from Chengdu Daxan Innovative Medical Tech. Co., Ltd.

See all devices from Chengdu Daxan Innovative Medical Tech. Co., Ltd. →

Properties

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

Other properties (8)

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