FDA.report

Western/Scott Fetzer

Primary DI
B929MXS6030
Brand
Western/Scott Fetzer
Company
WESTERN/SCOTT FETZER COMPANY
Model
MXS-603
Catalog number
MXS-603
Device description
INFINITY 1 KNOB"E"CYL 2015 PSI
Published
2022-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
B929MXS6030PrimaryHIBCC0

GMDN Terms

TermDefinition
Fixed medical gas cylinder regulatorA gas-regulating component 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. It includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.

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

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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
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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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