Enteral Feeding

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name: Enteral Feeding FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Device Name: Guardian Warmer w/ Control Box Hangers FDA UDI
Model / Reference: NGW2000 FDA UDI
Description: Guardian Warmer w/ Control Box Hangers FDA UDI

Identifiers

Primary DI / UDI-DI: 00020451100999 FDA UDI
510(k) Number: K122449 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Conduction blood/fluid warmer

Enteral Feeding by Medela LLC — 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

K122449 also covers:

Enteral Feeding — Medela LLC
Enteral Feeding — Medela LLC

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

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Manufacturer

Manufacturer: Medela LLC

Sources (1)

FDA UDI 4b512ce2-f407-4c1a-b316-9cfaecf32db4 35 fields · synced May 30, 2026