FDA.report

Mini Oxygen Regulator

Primary DI
00616784521435
Brand
Mini Oxygen Regulator
Company
DYNAREX CORPORATION
Model
5214
Device description
CGA870 Mini Oxygen Regulator, Brass Core w/ Alum. Sleeve, 0-4 LPM, Barb Outlet
Published
2020-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications

CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784521435PackageGS15In Commercial Distribution
00616784521411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784521435006167845214356167845214350616784521435
00616784521411006167845214116167845214110616784521411

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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