FDA.reportPublic FDA data

Silicone Sump Drain Tube

Primary DI
14710961935909
Brand
Silicone Sump Drain Tube
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2016-0320
Published
2021-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
14710961935909PrimaryGS10
04710961935902Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471096193590914710961935909
04710961935902047109619359024710961935902

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.

Regulatory Flags#

DUNS number
656763489
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14711182607989FixPad Anchoring Device1800-00052021-11-15
04710961933472Silicone Supra-Pubic Catheter (Ordinary Balloon)1857-02122016-03-15
04710961934127Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02122016-03-11
04710961934134Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02142016-03-11
04710961934141Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02162016-03-11
04710961934158Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02182016-03-11
04710961934165Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02202016-03-11
04710961934172Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02222016-03-11
04710961934189Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02242016-03-11
04710961934196Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82122016-03-15
04710961934202Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82142016-03-15
04710961934219Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82162016-03-15
04710961934226Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82182016-03-15
04710961934233Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-8220 2016-03-15
04710961934240Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82222016-03-15
04710961934257Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82242016-03-15
04710961937531Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02102016-03-15
04710961937548Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02122016-03-15
04710961937555Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02142016-03-15
04710961937562Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02162016-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380208942JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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10885380208973JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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10885380208997JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209000JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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10885380209024JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209031JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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10885380209154JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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10885380209185JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209192JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209208JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209215JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
14026704912794TAUTTELEFLEX INCORPORATEDGBW2024-06-19
14026704912800TAUTTELEFLEX INCORPORATEDGBW2024-06-19