AccessGUDID - DEVICE: MADA MEDICAL PRODUCTS, INC. (00815160020276)

GUDID

Device Identifier (DI) Information

Brand Name: MADA MEDICAL PRODUCTS, INC.
Version or Model: 1631E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1631E
Company Name: MADA MEDICAL PRODUCTS, INC

Primary DI Number: 00815160020276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048411862 *Terms of Use

Device 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. A 370C cart is included.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31760	Fixed-regulator oxygen refillable cylinder	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 colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb8c50c7-5a36-45a7-b42b-576fe1d4d7a5
Public Version Date: March 10, 2021
Public Version Number: 3
DI Record Publish Date: October 26, 2015