Drentech Pump 400 ml Round Drainage w/trocar Fr 19 10463

GUDID 18034139290840

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 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 400 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.

REDAX SPA

Closed-wound drainage kit

• Primary Device ID: 18034139290840
• NIH Device Record Key: 54db38c1-10f5-4d5d-86c0-d4543f691251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drentech Pump 400 ml Round Drainage w/trocar Fr 19
• Version Model Number: 10463
• Catalog Number: 10463
• Company DUNS: 338664915
• Company Name: REDAX SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it
• Phone: +17868187337
• Email: christian.costantini@redax.it

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034139290843 [Primary]
GS1	18034139290840 [Package]; Contains: 08034139290843; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-12
• Device Publish Date: 2021-05-04

Devices Manufactured by REDAX SPA

• 08034139290959 - Universal connector 1/4 x 1/4 Fr 24-36: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139290970 - Connector for drainage Fr 32-40: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 08034139290980 - Y connector 3/8 Fr 36-40: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139291014 - Y connector 3/8 1/4 1/4 Fr 24-32: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139291021 - Y connector 1/4 1/4 1/4 Fr 24-32: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139291045 - Y connector 3/8 Fr 15-20: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139291120 - Connector for Spiral Drain Fr 15-19: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
• 18034139295494 - Y connector 1/4 Fr 18-24: 2021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.