MADA MEDICAL PRODUCTS, INC. - A container designed as a refillable cylinder - MADA MEDICAL PRODUCTS, INC

Duns Number:048411862

Device Description: A container designed as a refillable cylinder with an integrated pressure regulator used t 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

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More Product Details

Catalog Number

1533

Brand Name

MADA MEDICAL PRODUCTS, INC.

Version/Model Number

1533

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

2f144c65-b9d5-47fa-be04-03a55b7ae688

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

October 26, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MADA MEDICAL PRODUCTS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 17