FDA.report

Silicone Sump Drain Tube

Primary DI
04710961935889
Brand
Silicone Sump Drain Tube
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2016-0220
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

Related Records

Product Codes

CodeName
GBWCatheter, Peritoneal

Product Code Classifications

CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14710961935886PrimaryGS10
04710961935889Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471096193588614710961935886
04710961935889047109619358894710961935889

GMDN Terms

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

Regulatory Flags

DUNS number
656763489
Device count
5
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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