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Rusch

FDA UDI

Class II (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
RUSCH Gold 2 Way Foley Catheter FDA UDI
Model / Reference
IPN929751 FDA UDI
Description
RUSCH Gold 2 Way Foley Catheter FDA UDI

Identifiers

Catalog Number
180730140 FDA UDI
Primary DI / UDI-DI
14026704926982 FDA UDI
FDA Product Code
KOD FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Rusch by Teleflex Incorporated — Class II — 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 f0844e0e-ee7e-454a-93d2-5a8c0c1cb1ad 35 fields · synced May 30, 2026