FDA.reportPublic FDA data

Flotec

Primary DI
B741CH0
Brand
Flotec
Company
FLOTEC INC
Model
Hose Assembly - Canadian Standard
Published
2021-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B741CH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen low pressure tubingA length of flexible tube intended to conduct compressed oxygen (O2) from an O2 terminal unit or O2 cylinder to a medical device that functions with O2 (e.g., ventilators, anaesthesia units, anaesthesia systems, analgesia units and other O2 dependent respiratory devices). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is intended for use within a static clinical environment (e.g., intensive care), is colour-coded for oxygen, and reinforced (e.g., with woven polyester or cotton). It is available in various lengths, including standard coil lengths. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103643730
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B741HA0FlotecHose Assembly2021-10-07
B741DL0FlotecInGage Regulator2020-02-27
B741MC0FlotecMass Casualty Assembly2020-02-27
B741RW0FlotecRW Regulator2020-02-27
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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00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
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10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
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10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
20197344010070HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-01-12
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10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
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10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
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10197344165315MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26
10197344165322MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26
14026704657060HUDSON RCITELEFLEX INCORPORATEDBYX2025-07-07
14026704656575HUDSON RCITELEFLEX INCORPORATEDBYX2025-07-03