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Rusch

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
RUSCH FDA UDI
Generic Name
Universal patient tubing holder, non-sterile FDA UDI
Device Name
Adhesive patch, big FDA UDI
Model / Reference
IPN044966 FDA UDI
Description
Adhesive patch, big FDA UDI

Identifiers

Catalog Number
546231-000000 FDA UDI
Primary DI / UDI-DI
24026704066128 FDA UDI
510(k) Number
K952187 FDA UDI
FDA Product Code
KOB FDA UDI
GMDN Term
Universal patient tubing holder, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Universal patient tubing holder, non-sterile

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

Similar devices

Also classified as Universal patient tubing holder, non-sterile.

Cleared under the same submission

K952187 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI bf28e5f0-6c95-475a-af4d-73eb26f07d34 37 fields · synced May 30, 2026