| Primary Device ID | 18034139297030 | 
| NIH Device Record Key | 8e103652-5fca-4f8d-be5a-66f84022a123 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Connector for silicone Fr 19 | 
| Version Model Number | 10551 | 
| Catalog Number | 10551 | 
| 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 | 
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | |
| Phone | +17868187337 | 
| christian.costantini@redax.it | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 08034139297033 [Primary] | 
| GS1 | 18034139297030 [Package] Contains: 08034139297033 Package: Box [50 Units] In Commercial Distribution | 
| GCD | Connector, Catheter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-05-19 | 
| Device Publish Date | 2021-05-11 | 
| 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. |