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Mini CGA 540 style O2 Regulator - 0-15 LPM

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Mini CGA 540 style O2 Regulator; 0-15 LPM FDA UDI
Generic Name
Non-fixed medical gas cylinder regulator FDA UDI
Device Name
Mini CGA 540 style O2 Regulator; 0-15 LPM FDA UDI
Model / Reference
RES045 FDA UDI
Description
Mini CGA 540 style O2 Regulator; 0-15 LPM FDA UDI

Identifiers

Catalog Number
RES045 FDA UDI
Primary DI / UDI-DI
00848530060718 FDA UDI
FDA Product Code
CAN FDA UDI
GMDN Term
Non-fixed medical gas cylinder regulator FDA UDI
Models / Variants
Mini CGA 540 style O2 Regulator FDA UDI
0-15 LPM 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-fixed medical gas cylinder regulator

Mini CGA 540 style O2 Regulator - 0-15 LPM by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — 2 models

Similar devices

Also classified as Non-fixed medical gas cylinder regulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI dd7298e0-72a5-4768-a7e7-2813bc42bea1 35 fields · synced May 30, 2026