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Rusch

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
RUSCH FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
Disposable FDA UDI
Model / Reference
IPN052011 FDA UDI
Description
Disposable FDA UDI

Identifiers

Catalog Number
345124 FDA UDI
Primary DI / UDI-DI
04026704543021 FDA UDI
FDA Product Code
FBW FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5520 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

No

FDA UDI

Combination Product

No

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

Dimensions & Sizes

Size
Width — 3 Inch FDA UDI
Length — 19.5 Inch FDA UDI
Height — 0.31 Inch FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Rusch by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 08994cf6-0518-4e4d-97c0-97614471faf6 37 fields · synced May 30, 2026