Oxygen Regulator

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Oxygen Regulator FDA UDI
Generic Name: Fixed-regulator oxygen refillable cylinder FDA UDI
Device Name: ***PRIVATE LABELED*** Mini CGA 870 Style O2 Regulator, 0-4lpm, Pediatric FDA UDI
Model / Reference: RES046PL FDA UDI
Description: ***PRIVATE LABELED*** Mini CGA 870 Style O2 Regulator, 0-4lpm, Pediatric FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530100469 FDA UDI
FDA Product Code: CAN FDA UDI
GMDN Term: Fixed-regulator oxygen refillable cylinder 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Fixed-regulator oxygen refillable cylinder

Oxygen Regulator by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fixed-regulator oxygen refillable cylinder.

MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
LIFE®SoftPac — Mv Life LLC · Class I
MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
MVA1 Viproxy — CAVAGNA GROUP SPA · Class I
ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
MADA MEDICAL PRODUCTS, INC — MADA MEDICAL PRODUCTS, INC. · 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: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI 66393ccb-d821-4cb5-bd76-5e50940de2a7 34 fields · synced May 30, 2026