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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
Blood stream indicator injector, mechanical FDA UDI
Device Name
Thermoset™ Probe FDA UDI
Model / Reference
41422-27 FDA UDI
Description
Thermoset™ Probe FDA UDI

Identifiers

Catalog Number
414220427 FDA UDI
Primary DI / UDI-DI
00840619047276 FDA UDI
510(k) Number
K884318 FDA UDI
FDA Product Code
KRB FDA UDI
GMDN Term
Blood stream indicator injector, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1915 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: Blood stream indicator injector, mechanical

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

Similar devices

Also classified as Blood stream indicator injector, mechanical.

Cleared under the same submission

K884318 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 a74a9dae-6224-4ce5-b58d-068b5bc6ca5e 36 fields · synced May 30, 2026