Thoracic Catheter, Angled Fr 36 21836

GUDID 18034139293827

This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.

REDAX SPA

Pleural catheter

• Primary Device ID: 18034139293827
• NIH Device Record Key: 0b7ddf24-9292-4fd4-ad4f-c74289315c1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoracic Catheter, Angled Fr 36
• Version Model Number: 21836
• Catalog Number: 21836
• 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
• 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
• 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	08034139293820 [Primary]
GS1	18034139293827 [Package]; Contains: 08034139293820; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• GBX: Catheter, Irrigation

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: 2021-05-13
• Device Publish Date: 2021-05-05

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.