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Level 1

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Level 1 FDA UDI
Generic Name
Circulating-air whole-body heating system control unit FDA UDI
Model / Reference
L1-Hose FDA UDI

Identifiers

Primary DI / UDI-DI
15019517100280 FDA UDI
510(k) Number
K181699 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Circulating-air whole-body heating system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-air whole-body heating system control unit

Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-air whole-body heating system control unit.

Cleared under the same submission

K181699 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI f8884519-8cc8-40ca-ab3b-1c8e322e5845 33 fields · synced May 29, 2026