| Primary Device ID | 00763000512927 |
| NIH Device Record Key | 375d660b-3759-4f52-be7b-f5c598daa5d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BB8P93R3 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000512927 [Primary] |
| 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 | 2021-03-08 |
| Device Publish Date | 2021-02-27 |
| 00763000893910 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40 |
| 00763000893941 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40 |
| 00763000988258 - NA | 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER |
| 00763000988760 - NA | 2024-12-20 CUSTOM PACK BB1F66R26 CASPER |
| 00763000973391 - Sphere-9™ Catheter | 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR |
| 00763000986704 - NA | 2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC |
| 00763000986773 - NA | 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK |
| 20763000986814 - NA | 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES |