FDA.reportPublic FDA data

Western/Scott Fetzer

Primary DI
B929M1320P0
Brand
Western/Scott Fetzer
Company
Western Enterprises
Model
M1-320-P
Catalog number
M1-320-P
Device description
REG. M1 SERIES PRESET 50 PSI
Published
2022-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
B929M1320P0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-800-783-7890SALES@WESTERNENTERPRISES.COM

Regulatory Flags#

DUNS number
148634731
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B929N4AI096FHTOHF0Western Enterprises, IncN4AI-096FHTOHFN4AI-096FHTOHF2026-05-14
B929N4SU120FNNCHM0Western Enterprises, IncN4SU-120FNNCHMN4SU-120FNNCHM2026-05-06
B929C4AIK072FHTFHT0Western/Scott FetzerC4AIK072FHTFHTC4AIK072FHTFHT2025-11-07
B929C4CO072FP4FNN0Western/Scott FetzerC4CO-072FP4FNNC4CO-072FP4FNN2025-09-23
B929C4OX072FP4OHF0Western/Scott FetzerC4OX-072FP4OHFC4OX-072FP4OHF2025-06-17
B929C4AI096FHTMBA0Western/Scott FetzerC4AI-096FHTMBAC4AI-096FHTMBA2025-05-14
B929C4AI120CHMBLK0Western/Scott FetzerC4AI-120CHMBLKC4AI-120CHMBLK2025-05-14
B929C4OX120CHMBLK0Western/Scott FetzerC4OX-120CHMBLKC4OX-120CHMBLK2025-05-14
B929CROC97920Roberts OxygenCROC-9792CROC-97922025-01-07
B939CROC97910Roberts Oxygen Co. Inc.CROC-9791CROC-97912025-01-07
B929C4OX030FNNMP40Western/Scott FetzerC4OX-030FNNMP4C4OX-030FNNMP42023-01-11
B929N4OX300FP4OHM0Western/Scott FetzerN4OX-300FP4OHMN4OX-300FP4OHM2023-01-07
B929N4OX600FNNBLK0Western/Scott FetzerN4OX-600FNNBLKN4OX-600FNNBLK2023-01-06
B929N4OX600FNNMP40Western/Scott FetzerN4OX-600FNNMP4N4OX-600FNNMP42023-01-07
B929C4OXW072FNNFP40Western/Scott FetzerC4OXW072FNNFP4C4OXW072FNNFP42024-05-06
B929C4OX012FHTMP20Western/Scott FetzerC4OX-012FHTMP2C4OX-012FHTMP22024-03-08
B929N4OX180OHFOXM0Western/Scott FetzerN4OX-180OHFOXMN4OX-180OHFOXM2024-02-19
B929N4OX192FNNFNN0Western/Scott FetzerN4OX-192FNNFNNN4OX-192FNNFNN2024-01-25
B929C4OX048FNNMP20Western/Scott FetzerC4OX-048FNNMP2C4OX-048FNNMP22023-12-14
B929C4OX240OHMMP40Western/Scott FetzerC4OX-240OHMMP4C4OX-240OHMMP42023-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
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