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 NOT 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 FDA UDI
Model / Reference: 1531E 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 NOT 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 FDA UDI

Identifiers

Catalog Number: 1531E FDA UDI
Primary DI / UDI-DI: 00815160020153 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

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Implantable

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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

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Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

Yes

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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

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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

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Manufacturer

Manufacturer: Mada Medical Products, Inc.

Sources (1)

FDA UDI 4d65b646-c976-480c-9518-487733382463 35 fields · synced May 30, 2026