FDA.report

Silicone Vac Drain Kit +J connector

Primary DI
04711182625399
Brand
Silicone Vac Drain Kit +J connector
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2014-9421J
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCDConnector, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14711182625396PrimaryGS10
04711182625399Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471118262539614711182625396
04711182625399047111826253994711182625399

GMDN Terms

TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
656763489
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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14711182608306Silicone T Drainage Set With Eyes1910-82202023-10-24
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04711182608163Rystora Skin Protector-SpraySY010302022-01-31
04710961934844Silicone C.W.V. Reservoir2013-06152022-01-31
04710961934851Silicone C.W.V. Reservoir2013-06202022-01-31
04710961934868Silicone C.W.V. Reservoir2013-06402022-01-31
04710961934875Silicone C.W.V. Reservoir (Top Outlet)2013-16402022-01-31
04710961934882Silicone C.W.V. Reservoir2013-09102022-01-31
04710961934899Silicone C.W.V. Reservoir2013-09152022-01-31
04710961934905Silicone C.W.V. Reservoir2013-09202022-01-31
04710961934912Silicone C.W.V. Reservoir2013-09402022-01-31
04710961934967Silicone Flat Drain2014-00522022-01-31
04710961934974Silicone Flat Drain2014-00712022-01-31
04710961934981Silicone Flat Drain2014-00722022-01-31
04710961934998Silicone Flat Drain2014-01012022-01-31
04710961935001Silicone Flat Drain2014-01022022-01-31
04710961935018Silicone Flat Drain2014-01312022-01-31
04710961935025Silicone Flat Drain2014-01322022-01-31
04710961935032Silicone Flat Drain Kit2014-90512022-01-31
04710961935049Silicone Flat Drain Kit2014-90522022-01-31

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50192253042830ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042854ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042861ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042878ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042885ArgyleCardinal Health 200, LLCGCD2025-02-27
24026704933123PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933130PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933147PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933154PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
07540198003016FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
07540198003115FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
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04710961934974Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934981Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934998Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935001Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935018Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935025Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935032Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935049Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935056Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935063Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935070Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935087Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935094Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935100Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935117Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31