FDA.reportPublic FDA data

MADA MEDICAL

Primary DI
00815160020665
Brand
MADA MEDICAL
Company
MADA MEDICAL PRODUCTS, INC
Model
8250
Device description
A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of an oxygen (O2) cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure, typically 3 - 5 bar. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815160020665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815160020665008151600206658151600206650815160020665

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen cylinder regulatorA reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of an oxygen (O2) cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure, typically 3 - 5 bar. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-460-0454dianelind@madamedical.com

Regulatory Flags#

DUNS number
048411862
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815160020573MADA MEDICAL PRODUCTS,INC.2772772018-08-20
00815160020597MADA MEDICAL PRODUCTS,INC.277-220V277-220V2018-08-20
00815160021310MADA MEDICAL PRODUCTS, INC.R1836GBHF-25GPR1836GBHF-25GP2024-04-22
00815160021129MADA MEDICAL PRODUCTS, INC.7000-MVP7000-MVP2023-06-27
00815160020498MADA MEDICAL PRODUCTS, INC.1301M1301M2023-09-02
00815160020504MADA MEDICAL PRODUCTS, INC.1301ME1301ME2023-09-02
00815160021280MADA MEDICAL PRODUCTS, INC.R1835-25GBHF-25R1835-25GBHF-252023-09-02
00815160021297MADA MEDICAL PRODUCTS, INC.1415MS1415MS2023-09-02
00815160021303MADA MEDICAL PRODUCTS, INC.1529E1529E2023-09-02
00815160021327MADA MEDICAL PRODUCTS, INC.1515A-151515A-152023-09-02
00815160021334MADA MEDICAL PRODUCTS, INC.1630-151630-152023-09-02
00815160021341MADA MEDICAL PRODUCTS, INC.1630-A151630-A152023-09-02
00815160021358MADA MEDICAL PRODUCTS, INC.1630A-15E1630A-15E2023-09-02
00815160021365MADA MEDICAL PRODUCTS, INC.163016302023-09-02
00815160021372MADA MEDICAL PRODUCTS, INC.1616-15E1616-15E2023-09-02
00815160021389MADA MEDICAL PRODUCTS, INC.1630M-15E1630M=15E2023-09-02
00815160021396MADA MEDICAL PRODUCTS, INC.1616-AE1616-AE2023-09-02
00815160021235MADA MEDICAL PRODUCTS, INC.1701-A1701-A2023-08-05
00815160021242MADA MEDICAL PRODUCTS, INC.1701-81701-82023-08-05
00815160021259MADA MEDICAL PRODUCTS, INC.135913592023-08-05

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