| Primary Device ID | 20763000215570 |
| NIH Device Record Key | 2e250d16-d240-470e-b08c-3be6a65df895 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB10U55R |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000215569 [Primary] |
| GS1 | 20763000215570 [Package] Contains: 00763000215569 Package: PK [10 Units] In Commercial Distribution |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-10 |
| Device Publish Date | 2018-11-08 |
| 00763000763152 - NA | 2025-10-07 SW APP P7A2C11 ALTAVIVA CLINICIAN |
| 00763000763817 - NA | 2025-10-07 SW APP P7A2P11 ALTAVIVA PATIENT |
| 00763000929367 - Altaviva™ | 2025-10-07 KIT P7K2C001 ALTAVIVA CLINICIAN |
| 00763000935627 - Altaviva™ | 2025-10-07 KIT P7K2P001 ALTAVIVA PATIENTA^ |
| 00763000936433 - Altaviva™ | 2025-10-07 INS P7850N ALTAVIVA NEUROSTIMULATOR RC |
| 00763000936440 - NA | 2025-10-07 ACCESSORY P71001 POCKET DISSECTOR |
| 00199150050161 - NA | 2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK |
| 00199150050178 - NA | 2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E |