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ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
ICU Medical FDA UDI
Generic Name
Centrally-inserted central venous catheter FDA UDI
Device Name
Central Venous Catheter, Heparin Coated, 2 Lumen, 16/16 G, 20 cm, PMAP, Expanded Kit FDA UDI
Model / Reference
41406-23 FDA UDI
Description
Central Venous Catheter, Heparin Coated, 2 Lumen, 16/16 G, 20 cm, PMAP, Expanded Kit FDA UDI

Identifiers

Catalog Number
414060423 FDA UDI
Primary DI / UDI-DI
00840619046422 FDA UDI
510(k) Number
K091268 FDA UDI
FDA Product Code
DQE FDA UDI
GMDN Term
Centrally-inserted central venous catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1230 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

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: Centrally-inserted central venous catheter

ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centrally-inserted central venous catheter.

Cleared under the same submission

K091268 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 397fe06e-4ffc-4417-b6d5-ea1c80d365f0 36 fields · synced May 30, 2026