FDA.reportPublic FDA data

FlexTube

Primary DI
07540198003023
Brand
FlexTube
Company
Prime Pacific Health Innovations Corporation
Model
Connector
Catalog number
8232-50
Device description
The FlexTube is a connector intended to be used with the AquaWing Treatment Table. It fits the flow-through fitting of the table and allows water to pass through the portion of the table that supports the patients legs during treatment.
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GCDConnector, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540198003023PrimaryGS10
07540198003115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198003023075401980030237540198003023
07540198003115075401980031157540198003115

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Regulatory Flags#

DUNS number
250896255
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540198001005Pro-FitRegular Kit with stop disc81162016-09-23
07540198001012Pro-FitSmall Kit with stop disc81172016-09-23
07540198001029Pro-FitRegular Kit with guide rings81432016-09-23
07540198001036Pro-FitSmall Kit with guide rings81442016-09-23
07540198001067Pro-Fit Eco-FlexRegular Kit with stop disc8116-EF2016-09-23
07540198001111Pro-Fit Eco-FlexSmall Kit with stop disc8117-EF2016-09-23
07540198001166Pro-Fit Eco-FlexRegular Kit with guide rings8143-EF2016-09-23
07540198001210Pro-Fit Eco-FlexSmall Kit with guide rings8144-EF2016-09-23
07540198001241Pro-FitUniversal Kit91252016-09-23
07540198001272Pro-Fit Eco-FlexUniversal Kit9125-EF2016-09-23
07540198000305Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000312Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000329Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000336Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000343Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000350Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000367Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000374Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000381Pro-FitUniversal Speculum Pack91262016-09-30
07540198000398Pro-FitUniversal Speculum Pack91262016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704924254PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-06-24
14026704937223PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937377PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937384PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937391PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937407PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937339PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-07
14026704911858PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
10192253042900ArgyleCardinal Health 200, LLCGCD2025-03-07
10192253042832ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042856ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042863ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042870ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042887ArgyleCardinal Health 200, LLCGCD2025-02-27
14026704933126PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933133PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933140PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933157PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
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14710961935053Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935060Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935077Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31