FDA.reportPublic FDA data

Silicone Sump Drain Tube

Primary DI
04711182605759
Brand
Silicone Sump Drain Tube
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2016-1320
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
34711182605750PrimaryGS10
04711182605759Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3471118260575034711182605750
04711182605759047111826057594711182605759

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
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
10885380208959JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208966JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208973JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208980JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208997JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209000JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209017JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209024JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209031JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209048JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209055JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209062JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209079JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209086JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209093JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209109JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209116JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209123JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209130JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209147JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209154JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209161JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209178JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
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