HypothermX LG Intravenous Fluid and Blood Warmer

FDA UDI

Class II (US FDA UDI)

by Emit Corporation

Identity

Trade Name: HypothermX LG Intravenous Fluid and Blood Warmer FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Model / Reference: FA100004 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850003277042 FDA UDI
510(k) Number: K103801 FDA UDI
FDA Product Code: LGZ FDA UDI
GMDN Term: Conduction 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Conduction blood/fluid warmer

HypothermX LG Intravenous Fluid and Blood Warmer by Emit Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conduction blood/fluid warmer.

Ranger™ — 3M COMPANY · Class II
ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
ASTOLINE — Stihler Electronic GmbH · Class II
ASTOTHERM® PLUS — Stihler Electronic GmbH · Class II
EXPRESS FLUID WARMER — NxStage Medical, Inc. · Class II
°M Warmer System - Charger — Mequ A/S · Class II
ASTOFLO® PLUS ECO — Stihler Electronic GmbH · Class II

Cleared under the same submission

K103801 also covers:

HypothermX HX100 Intravenous Fluid and Blood Warmer — EMIT CORPORATION

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: Emit Corporation

Sources (1)

FDA UDI 3a6241de-2449-410e-8c23-8e4818384ed1 33 fields · synced Jun 1, 2026