FDA.reportPublic FDA data

Resp-O2 Oxygen Regulator CGA 870 Style

Primary DI
00840117309944
Brand
Resp-O2 Oxygen Regulator CGA 870 Style
Company
Dynarex Corporation
Model
36351
Device description
Resp-O2 Oxygen Regulator CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-8 LPM
Published
2022-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840117309951PackageGS15In Commercial Distribution
00840117309944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117309951008401173099518401173099510840117309951
00840117309944008401173099448401173099440840117309944

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed medical gas 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 a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixtures) cylinder to lower high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). 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 (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true

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00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
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00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
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00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
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