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Umbili-Cath

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
UMBILI-CATH FDA UDI
Generic Name
Umbilical catheter FDA UDI
Device Name
A Triple-Lumen Polyurethane Umbilical Catheter, 5 French FDA UDI
Model / Reference
Triple-Lumen Polyurethane FDA UDI
Description
A Triple-Lumen Polyurethane Umbilical Catheter, 5 French FDA UDI

Identifiers

Catalog Number
4385005 FDA UDI
Primary DI / UDI-DI
H67143850050 FDA UDI
510(k) Number
K940952 FDA UDI
FDA Product Code
FOS FDA UDI
GMDN Term
Umbilical catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 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

No

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
Length — 37 Centimeter FDA UDI
Catheter Gauge — 5 French FDA UDI

Category: Umbilical catheter

Umbili-Cath by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Umbilical catheter.

Cleared under the same submission

K940952 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI eeadd694-9fa5-4804-8619-f94c1dd49da2 37 fields · synced Jun 9, 2026