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SureStep™ Foley Tray System with Bardex® Lubricath Temp Sensing Foley Catheter A119418M

by C. R. Bard, Inc.

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 Number00801741073717 UDI-DI Date6 Dec 2015ListedStatusListed 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  • Withdrawn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
SureStep™ Foley Tray System with Bardex® Lubricath Temp Sensing Foley Catheter
Generic Name
Indwelling urethral catheterization kit, adult
Model / Ref / Catalog
A119418M
Description
SureStep® Foley Tray System Bardex® Lubricath® Temperature Sensing Foley Catheter Tray 350 ml Urine Meter
Primary DI / UDI-DI
00801741073717
FDA Product Code
EZC
GMDN Term
Indwelling urethral catheterization kit, adult
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 18 French

Related devices

Category: Indwelling urethral catheterization kit, adult

Other devices from C. R. Bard, Inc.

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Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (6)

  • Implantable: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No