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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
Basic intravenous administration set, noninvasive FDA UDI
Device Name
ROOM TEMP. C/O KIT FDA UDI
Model / Reference
46050-38 FDA UDI
Description
ROOM TEMP. C/O KIT FDA UDI

Identifiers

Catalog Number
460500438 FDA UDI
Primary DI / UDI-DI
00887709045767 FDA UDI
510(k) Number
K884318 FDA UDI
FDA Product Code
KRB FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive 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

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

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: Basic intravenous administration set, noninvasive

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

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

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 5e7b6170-9738-4cff-b9d3-7be4dce1a2e6 36 fields · synced May 30, 2026