FDA.reportPublic FDA data

Flotec

Primary DI
B741RW0
Brand
Flotec
Company
FLOTEC INC
Model
RW Regulator
Published
2020-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
B741RW0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
3172736960QA@floteco2.com

Regulatory Flags#

DUNS number
103643730
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B741CH0FlotecHose Assembly - Canadian Standard2021-10-07
B741HA0FlotecHose Assembly2021-10-07
B741DL0FlotecInGage Regulator2020-02-27
B741MC0FlotecMass Casualty Assembly2020-02-27
B741TCB0FlotecT.O.A.D. Connection Box2022-01-28
B741FM0FlotecFlowmeter2020-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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