← Back to catalogue

SureStep™ Foley Tray System Add-A-Foley Catheter

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
SureStep™ Foley Tray System Add-A-Foley Catheter FDA UDI
Generic Name
Urethral catheterization support kit, urinary drainage FDA UDI
Device Name
SureStep® Foley Tray System Add-A-Foley Catheter 2000 ml Drainage Bag FDA UDI
Model / Reference
A399400 FDA UDI
Description
SureStep® Foley Tray System Add-A-Foley Catheter 2000 ml Drainage Bag FDA UDI

Identifiers

Catalog Number
A399400 FDA UDI
Primary DI / UDI-DI
00801741100369 FDA UDI
FDA Product Code
KNX FDA UDI
GMDN Term
Urethral catheterization support kit, urinary drainage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urethral catheterization support kit, urinary drainage

SureStep™ Foley Tray System Add-A-Foley Catheter by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral catheterization support kit, urinary drainage.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI 025d85d4-6bfd-4c60-b968-7cc1e41af308 35 fields · synced Jun 8, 2026