FDA.reportPublic FDA data

Oxygen Regulator

Primary DI
00616784521237
Brand
Oxygen Regulator
Company
DYNAREX CORPORATION
Model
5212
Device description
CGA870 Oxygen Regulator, Brass Core w/ Aluminum Sleeve, 0-15 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

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
00616784521237PackageGS15In Commercial Distribution
00616784521213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784521237006167845212376167845212370616784521237
00616784521213006167845212136167845212130616784521213

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784124810Transducer Covers, For Ultrasound Imaging Systems, 5.3 cm x 20 cm12482016-09-24
00616784426211Piston Irrigation Syringe,Ring Top Syringe with Protective Cap Tubing Adaptor42622021-09-01
00616784020518Vivid-Essential Rollator with 6" Casters, Red102052019-10-07
00616784020617Vivid-Essential Rollator with 6" Casters, Blue102062019-10-07
00616784703015"IV Administration Set, 10 mL, Non-Toxic, 83"" "70302016-09-24
00616784703312"IV Administration Set, Non-Toxic, 15 mL, 106"" (269.2 cm)"70332016-09-24
00616784703411"IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)"70342016-09-24
00616784703718"IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)"70372016-09-24
00616784704814"IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) "70482016-09-24
00616784704913"IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)"70492016-09-24
00616784705118"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/ mL, 83"" (210.8 cm) "70512016-09-24
00616784705217"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/mL, 78"" (198.1 cm) "70522016-09-24
00616784705415Needleless PRN Luer Connectors, Non-Toxic70542016-09-24
00840117334502Pre-Filled Saline Flush Syringe, 5 mL70582024-03-07

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