Roberts Oxygen Co. Inc.

FDA UDI

Class I (US FDA UDI)

by Western Enterprises, Inc.

Identity

Trade Name: Roberts Oxygen Co. Inc. FDA UDI
Generic Name: Fixed medical gas cylinder regulator FDA UDI
Device Name: NEXTGEN 3/4-16 CONN ROBERTS O2 FDA UDI
Model / Reference: CROC-9791 FDA UDI
Description: NEXTGEN 3/4-16 CONN ROBERTS O2 FDA UDI

Identifiers

Catalog Number: CROC-9791 FDA UDI
Primary DI / UDI-DI: B939CROC97910 FDA UDI
FDA Product Code: CAN FDA UDI
GMDN Term: Fixed medical gas cylinder regulator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.2700 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Fixed medical gas cylinder regulator

Roberts Oxygen Co. Inc. by Western Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fixed medical gas cylinder regulator.

MedSource Oxygen Adapter — MEDSOURCE INTERNATIONAL LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
MVA1 Viproxy — CAVAGNA GROUP SPA · Class I
Cavagna — CAVAGNA NORTH AMERICA INC · Class I
EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
Control Devices — Control Devices, LLC · Class I
MVA2 Viproxy 1 Touch — CAVAGNA GROUP SPA · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Western Enterprises, Inc.

Sources (1)

FDA UDI ef202a61-5b28-4a0b-8d52-f248a7249d7f 34 fields · synced May 30, 2026