| Primary Device ID | 10860000559130 |
| NIH Device Record Key | e23d1b78-3fcb-455b-b15e-144cbff2a675 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cephus Catheter |
| Version Model Number | 0006560 |
| Company DUNS | 079172500 |
| Company Name | Sealcath, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com | |
| Phone | +1(877)917-1453 |
| support@sealcath.com |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Catheter Gauge | 30 French |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000559133 [Primary] |
| GS1 | 10860000559130 [Package] Contains: 00860000559133 Package: Box [10 Units] In Commercial Distribution |
| FCE | Enema kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2018-11-30 |
| 10860000559147 | 0006560 |
| 10860000559130 | 0006560 |
| 10860000559123 | 0006560 |
| 10860000559116 | 0006560 |
| 10860000559109 | 0006560 |