Silicone Reservoir 400 ml 10420

GUDID 18034139290642

The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors for connection to the drainage tube. The reservoir has a capacity of 400 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full.

REDAX SPA

Closed-wound/centesis drainage receptacle
Primary Device ID18034139290642
NIH Device Record Key3ed1d84d-840b-4c6c-9845-6763da608fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Reservoir 400 ml
Version Model Number10420
Catalog Number10420
Company DUNS338664915
Company NameREDAX SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108034139290645 [Primary]
GS118034139290642 [Package]
Contains: 08034139290645
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-12
Device Publish Date2021-05-04

Devices Manufactured by REDAX SPA

08034139290959 - Universal connector 1/4 x 1/4 Fr 24-362021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139290970 - Connector for drainage Fr 32-402021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
08034139290980 - Y connector 3/8 Fr 36-402021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291014 - Y connector 3/8 1/4 1/4 Fr 24-322021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291021 - Y connector 1/4 1/4 1/4 Fr 24-322021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291045 - Y connector 3/8 Fr 15-202021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291120 - Connector for Spiral Drain Fr 15-192021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139295494 - Y connector 1/4 Fr 18-242021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.

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