Mada Medical Products, Inc.

FDA UDI

Class I (US FDA UDI)

by Mada Medical Products, Inc.

Identity

Trade Name: MADA MEDICAL PRODUCTS, INC. FDA UDI
Generic Name: Fixed-regulator oxygen refillable cylinder FDA UDI
Device Name: A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and color-coded to denote O2 content. The cylinder may be made of steel, aluminum (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anesthesia, and for therapeutic purposes. A 370C cart is included. FDA UDI
Model / Reference: 1631 FDA UDI
Description: A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and color-coded to denote O2 content. The cylinder may be made of steel, aluminum (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anesthesia, and for therapeutic purposes. A 370C cart is included. FDA UDI

Identifiers

Catalog Number: 1631 FDA UDI
Primary DI / UDI-DI: 00815160020269 FDA UDI
FDA Product Code: BZN FDA UDI
GMDN Term: Fixed-regulator oxygen refillable cylinder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6175 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fixed-regulator oxygen refillable cylinder

Mada Medical Products, Inc. by Mada Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fixed-regulator oxygen refillable cylinder.

LIFE®SoftPac — Mv Life LLC · Class I
MVA1 Viproxy — CAVAGNA GROUP SPA · Class I
ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
MVA2 Viproxy 1 Touch — CAVAGNA GROUP SPA · Class I
DeVilbiss — DeVilbiss Healthcare LLC. · Class II
MediVitop — GCE, s.r.o. · Class I
LIFE®SoftPac — Mv Life LLC · Class I
DeVilbiss — DeVilbiss Healthcare LLC. · Class II

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: Mada Medical Products, Inc.

Sources (1)

FDA UDI d05d647b-3fd8-4031-aad9-8f4f5c2415bb 35 fields · synced Jun 8, 2026