Home GUDID 08034139297132 Drentech Pump 100 ml Smart Drain w/trocar Fr 19
Primary DI 08034139297132
Brand Drentech Pump 100 ml Smart Drain w/trocar Fr 19
Company REDAX SPA
Model 10413
Catalog number 10413
Device description The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage is characterized by a section equipped with drainage grooves, together with a round section portion. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device.
Published 2021-05-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18034139297139 Package GS1 10 In Commercial Distribution 08034139297132 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18034139297139 18034139297139 08034139297132 08034139297132 8034139297132
GMDN Terms# Term, Definition table Term Definition Closed-wound drain, non-bioabsorbable A tube-like, non-bioabsorbable 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 variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 338664915 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08034139292809 Thoracic Catheter, Straight Fr 12 20812 20812 2021-05-04 08034139292816 Thoracic Catheter, Straight Fr 15 20815 20815 2021-05-05 08034139292823 Thoracic Catheter, Straight Fr 18 20818 20818 2021-05-07 08034139292830 Thoracic Catheter, Straight Fr 21 20821 20821 2021-05-07 08034139292847 Thoracic Catheter, Straight Fr 24 20824 20824 2021-05-07 08034139292854 Thoracic Catheter, Straight Fr 28 20828 20828 2021-05-05 08034139292861 Thoracic Catheter, Straight Fr 30 20830 20830 2021-05-07 08034139292878 Thoracic Catheter, Straight Fr 33 20833 20833 2021-05-07 08034139292885 Thoracic Catheter, Straight Fr 36 20836 20836 2021-05-05 08034139293783 Thoracic Catheter, Angled Fr 24 21824 21824 2021-05-05 08034139293790 Thoracic Catheter, Angled Fr 28 21828 21828 2021-05-05 08034139293806 Thoracic Catheter, Angled Fr 30 21830 21830 2021-05-07 08034139293813 Thoracic Catheter, Angled Fr 33 21833 21833 2021-05-07 08034139293820 Thoracic Catheter, Angled Fr 36 21836 21836 2021-05-05 08034139290874 Drentech Pump 100 ml Round Drainage w/trocar Fr 15 10483 10483 2021-05-04 08034139294506 Flat Drain type Jackson-Pratt 3x7 mm 24100 24100 2021-05-03 08034139294513 Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar 24101 24101 2021-05-05 08034139294520 Flat Drain type Jackson-Pratt 3x7 mm 24110 24110 2021-05-05 08034139294537 Flat Drain type Jackson-Pratt 3x7 mm w/trocar 24111 24111 2021-05-05 08034139294544 Flat Drain 3/4 type Jackson-Pratt 4x10 mm 24120 24120 2021-05-07
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