Level 1

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Level 1 FDA UDI
Generic Name: Convection blood/fluid warmer FDA UDI
Model / Reference: HL-390-40 FDA UDI

Identifiers

Primary DI / UDI-DI: 10695085002833 FDA UDI
510(k) Number: K911383 FDA UDI
FDA Product Code: LGZ FDA UDI
GMDN Term: Convection blood/fluid warmer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Convection blood/fluid warmer

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

Similar devices

Also classified as Convection blood/fluid warmer.

Thermal Angel Ultra Battery 1 — ESTILL MEDICAL TECHNOLOGIES, INC. · Class II
Thermal Angel — ESTILL MEDICAL TECHNOLOGIES, INC. · Class II
TA-UPC Ultra Power Cable 3' — ESTILL MEDICAL TECHNOLOGIES, INC. · Class II
Level 1 — ICU MEDICAL, INC. · Class II
Level 1 — ICU MEDICAL, INC. · Class II
Level 1 — ICU MEDICAL, INC. · Class II
Level 1 — ICU MEDICAL, INC. · Class II
Level 1 — ICU MEDICAL, INC. · Class II

Cleared under the same submission

K911383 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI 421c942b-4011-4671-ae4b-7d60d418fd3d 33 fields · synced May 30, 2026