FDA.reportPublic FDA data

Silicone Sump Drain Tube

Primary DI
04711182605827
Brand
Silicone Sump Drain Tube
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2016-1220
Published
2021-12-15
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

Product Codes#

Code, Name table
CodeName
GBWCatheter, Peritoneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14711182605824PrimaryGS10
04711182605827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471118260582414711182605824
04711182605827047111826058274711182605827

GMDN Terms#

Term, Definition table
TermDefinition
Sump drainA sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.

Sterilization Methods#

Method table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14711182608306Silicone T Drainage Set With Eyes1910-82202023-10-24
14711182608313Silicone T Drainage Set With Eyes1910-82242023-10-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50749756035243DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-08
50749756035755DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-03
20801902197942ARROWTELEFLEX INCORPORATEDGBW2022-11-09
10653405050032CORE DYNAMICSConmed CorporationGBW2022-06-02
04710961935865Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935872Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935889Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935896Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935902Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605810Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605759Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935858Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-11-24
14543527251959Super Sheath CBDETOGO MEDIKIT CO.,LTD.GBW2021-05-14
M368395310GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953120GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953140GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953340GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953580GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
00827002026254CookCOOK INCORPORATEDGBW2020-10-02
00827002043855CookCOOK INCORPORATEDGBW2020-10-02
00827002052673CookCOOK INCORPORATEDGBW2020-10-02
00827002052680CookCOOK INCORPORATEDGBW2020-10-02
20801902162926ARROWTELEFLEX INCORPORATEDGBW2020-04-28
34026704656456TAUTTELEFLEX INCORPORATEDGBW2019-06-03
24026704656466TAUTTELEFLEX INCORPORATEDGBW2019-06-03
34026704656470TAUTTELEFLEX INCORPORATEDGBW2019-06-03
00801902005243ARROWTELEFLEX INCORPORATEDGBW2019-03-07
34026704656487TAUTTELEFLEX INCORPORATEDGBW2019-02-28
20801902121725ARROWTELEFLEX INCORPORATEDGBW2018-10-25
50885425501869CARDINAL HEALTHCardinal Health 200, LLCGBW2018-10-22