FDA.reportPublic FDA data

Western/Scott Fetzer

Primary DI
B929M1940P0
Brand
Western/Scott Fetzer
Company
WESTERN/SCOTT FETZER COMPANY
Model
M1-940-P
Catalog number
M1-940-P
Device description
REG. M1 SERIES PRESET 50 PSI
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

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
B929M1940P0PrimaryHIBCC0

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B929C4SUY072MP4FP40Western/Scott FetzerC4-SUC-072-MP4-FP4C4SUY072MP4FP42024-06-24
B929C4AIK036FHTFHT0Western/Scott FetzerC4AIK036FHTFHTC4AIK036FHTFHT2024-05-14
B929C4OXW072FNNFP40Western/Scott FetzerC4OXW072FNNFP4C4OXW072FNNFP42024-05-06
B929C4N2072FNNFP20Western/Scott FetzerC4N2-072FNNFP2C4N2-072FNNFP22024-05-01
B929C4OX012FHTMP20Western/Scott FetzerC4OX-012FHTMP2C4OX-012FHTMP22024-03-08
B929N4AI180OHFOXM0Western/Scott FetzerN4AI-180OHFOXMN4AI-180OHFOXM2024-02-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850027043852Precision Medical Inc.Precision Medical, Inc.CAN2026-02-25
00819601025790Alcon Laboratories Inc.Airgas Therapeutics, LLCCAN2026-02-19
00848530108168RegulatorsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-02-02
10848530108127RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
10848530108158RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
00199972000177CuraplexBOUND TREE MEDICAL, LLCCAN2026-01-23
00851440007483Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CAN2025-12-13
00848530107765Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-11-24
16977645350528XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350535XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350542SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350559SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350566SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350573SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350580SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350597SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350603XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350610XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350627XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350634XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350641XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350658XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
10848530107410React Regulator ValveSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-09-17
08592346978812MediVital EGCE, s.r.o.CAN2025-08-08
16977645350184SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350276SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350207SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350214SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350382SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350399SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16