| Primary Device ID | 00763000505448 |
| NIH Device Record Key | 4dd11eed-c72b-4571-82b0-85d665866f13 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB10Z55R2 |
| 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 | true |
| 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 | |
| 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 |
| 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 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| GS1 | 00763000505448 [Primary] |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| DWF | Catheter, cannula and tubing, vascular, 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 | 2021-02-23 |
| Device Publish Date | 2021-02-15 |
| 00763000147013 - SELECTSITE™ | 2021-02-26 CATHETER C304-HIS GLOBAL |
| 00763000343286 - NA | 2021-02-23 BELT 3560019 ENS ISTIM DISP 1PK GLBL MDR |
| 20763000504643 - NA | 2021-02-23 CUSTOM PACK BB9P10R2 2PK AV SUPLEM |
| 20763000504667 - NA | 2021-02-23 CUSTOM PACK BB2U38R3 5PK REPLCMNT |
| 20763000504681 - NA | 2021-02-23 CUSTOM PACK BB7Z95R2 5PK VENBYPASS |
| 00763000504694 - NA | 2021-02-23 CUSTOM PACK BB7A98R9 SAVLOOP |
| 20763000504711 - NA | 2021-02-23 CUSTOM PACK BB4C14R4 4PK BRIDGE |
| 20763000504735 - NA | 2021-02-23 CUSTOM PACK BB11M35R 5PK OXY PRIMING |