FDA.report

Western/Scott Fetzer

Primary DI
B929OPA5100
Brand
Western/Scott Fetzer
Company
WESTERN/SCOTT FETZER COMPANY
Model
OPA-510
Catalog number
OPA-510
Device description
PKGD: O2 REG 1/64-2LPM/CGA 540
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications

CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B929OPA5100PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
1-800-783-7890SALES@WESTERNENTERPRISES.COM

Regulatory Flags

DUNS number
148634731
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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

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B929C4OXW072FNNFP40Western/Scott FetzerC4OXW072FNNFP4C4OXW072FNNFP42024-05-06
B929C4N2072FNNFP20Western/Scott FetzerC4N2-072FNNFP2C4N2-072FNNFP22024-05-01
B929C4OX012FHTMP20Western/Scott FetzerC4OX-012FHTMP2C4OX-012FHTMP22024-03-08
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B929N4OX180OHFOXM0Western/Scott FetzerN4OX-180OHFOXMN4OX-180OHFOXM2024-02-19
B929N4OX192FNNFNN0Western/Scott FetzerN4OX-192FNNFNNN4OX-192FNNFNN2024-01-25
B929C4OX048FNNMP20Western/Scott FetzerC4OX-048FNNMP2C4OX-048FNNMP22023-12-14
B929C4AI240OHMFP40Western/Scott FetzerC4AI-240OHMFP4C4AI-240OHMFP42023-12-13
B929C4CO036MP4MP40Western/Scott FetzerC4CO-036MP4MP4C4CO-036MP4MP42023-12-13
B929C4OX240OHMMP40Western/Scott FetzerC4OX-240OHMMP4C4OX-240OHMMP42023-12-13
B929N4SU240OHMBLK0Western/Scott FetzerN4SU-240OHMBLKN4SU-240OHMBLK2023-12-13
B929C4NI012MP4SHF0Western/Scott FetzerC4NI-012MP4SHFC4NI-012MP4SHF2023-11-29
B929C4OX240CHMFP40Western/Scott FetzerC4OX-240CHMFP4C4OX-240CHMFP42023-11-29
B929N4SU240CHMMBA0Western/Scott FetzerN4SU-240CHMMBAN4SU-240CHMMBA2023-10-24
B929N4SU300FHTFHT0Western/Scott FetzerN4SU-300FHTFHTN4SU-300FHTFHT2023-10-24
B929C4CO096FP4FP40Western/Scott FetzerC4CO-096FP4FP4C4CO-096FP4FP42023-10-17
B929N4OX240FP4FP40Western/Scott FetzerN4OX-240FP4FP4N4OX-240FP4FP42023-10-04
B929CMNDR6000Western/Scott FetzerCMNDR-600CMNDR-6002023-08-11

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