MADA MEDICAL PRODUCTS, INC. 1335-1

GUDID 00815160020955

A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.

MADA MEDICAL PRODUCTS, INC

Oxygen therapy conserving regulator
Primary Device ID00815160020955
NIH Device Record Keye383053d-2916-4a81-b343-27a11d34b4cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMADA MEDICAL PRODUCTS, INC.
Version Model Number1335-1
Catalog Number1335-1
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815160020955 [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 Date2023-07-05
Device Publish Date2023-06-27

On-Brand Devices [MADA MEDICAL PRODUCTS, INC.]

00815160020740It is a demand valve with an adult mask and hose. A non-sterile device that is used to regulate
00815160020658.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020641.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020634.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020627.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020610.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020603An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from
00815160020580.A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (
00815160020559An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from
00815160020535A mains electricity (AC-powered) device designed to create compressed air and supply it directly
00815160020511A cylindrical sealable container typically made of disposable plastic materials used as a compon
00815160020399It is a demand valve with a hose without a mask. A non-sterile device that is used to regulate t
00815160020290A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020283A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020276A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020269A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020252A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020245A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020238A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020221A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020214A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020177A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020160A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020146A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020139A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020122A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020115A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020108A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020054A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020047A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020030A container designed as a refillable cylinder with an integrated pressure regulator used to hold
00815160020023A container designed as a refillable cylinder(FILLED) with an integrated pressure regulator used
00815160020016A container designed as a refillable cylinder(EMPTY) with an integrated pressure regulator used
00815160020009A container designed as a refillable cylinder(FILLED) with an integrated pressure regulator used
20815160020515A cylindrical sealable container typically made of disposable plastic materials used as a compon
10815160020518A cylindrical sealable container typically made of disposable plastic materials used as a compon
00815160021129A portable assembly of devices, which includes a non-surgical invasive component, intended to ma
00815160021112An electromechanical device designed to clean soft debris, plaque and stain build-up from the su
00815160021105A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or othe
00815160021099A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021082A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021075A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021068A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021051A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021044A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021037A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160021020A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mas
00815160021013A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mas
00815160021006A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli
00815160020993A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cyli

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