HomeFill® Oxygen System

FDA UDI

Class II (US FDA UDI)

by Ventec Life Systems, Inc.

Identity

Trade Name: HomeFill® Oxygen System FDA UDI
Generic Name: Oxygen compressor, home-use FDA UDI
Model / Reference: IOH200 FDA UDI

Identifiers

Catalog Number: IOH200 FDA UDI
Primary DI / UDI-DI: 00850018761307 FDA UDI
510(k) Number: K021685 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Oxygen compressor, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 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: Oxygen compressor, home-use

HomeFill® Oxygen System by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen compressor, home-use.

MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
DeVilbiss iFill — DeVilbiss Healthcare LLC. · Class II

Cleared under the same submission

K021685 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

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Manufacturer

Manufacturer: Ventec Life Systems, Inc.

Sources (1)

FDA UDI 8e4654e5-a143-4a15-a8f3-99ff51538fec 35 fields · synced May 31, 2026