MADA MEDICAL PRODUCTS, INC. 1515A-15

GUDID 00815160021327

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. A 1410 carry bag is included.

MADA MEDICAL PRODUCTS, INC

Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder Fixed-regulator oxygen refillable cylinder
Primary Device ID00815160021327
NIH Device Record Key5e6b5ea9-5ac8-48a9-9d86-9c67787fc055
Commercial Distribution StatusIn Commercial Distribution
Brand NameMADA MEDICAL PRODUCTS, INC.
Version Model Number1515A-15
Catalog Number1515A-15
Company DUNS048411862
Company NameMADA MEDICAL PRODUCTS, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com
Phone(201)460-0454
Emaildianelind@madamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815160021327 [Primary]

FDA Product Code

CANRegulator, Pressure, Gas Cylinder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-02

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