FDA.reportPublic FDA data

MADA MEDICAL PRODUCTS, INC.

Primary DI
00815160021259
Brand
MADA MEDICAL PRODUCTS, INC.
Company
MADA MEDICAL PRODUCTS, INC
Model
1359
Catalog number
1359
Device description
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.
Published
2023-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815160021259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815160021259008151600212598151600212590815160021259

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen therapy conserving regulatorA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
048411862
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
00815160021266MADA MEDICAL PRODUCTS, INC.1359-11359-12023-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
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G298153187280030NAControl Devices, LLCCAN2024-08-08
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G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30
G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26