| Primary Device ID | 20613994603610 |
| NIH Device Record Key | 45185c5d-c4d7-4128-865e-8b6e9072f8ab |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DLP2X81R4 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994603616 [Primary] |
| GS1 | 20613994603610 [Package] Contains: 00613994603616 Package: PK [5 Units] In Commercial Distribution |
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-22 |
| 00199150029815 - NA | 2025-07-18 CUSTOM PACK BB9J91R11 CP PRIME |
| 00199150029839 - NA | 2025-07-18 CUSTOM PACK BB12B96R7 1/4 SPECTRUM |
| 00199150031603 - NA | 2025-07-18 CUSTOM PACK BB2R88R9 PUMP/TABL |
| 00199150032457 - NA | 2025-07-18 CUSTOM PACK BB8L48R9 TABLE PK |
| 00199150033430 - NA | 2025-07-18 CUSTOM PACK BB12E24R9 UNC GOLD PD |
| 00199150033461 - NA | 2025-07-18 CUSTOM PACK BB12Q81R H/L 1/2 IN TU |
| 00199150033546 - NA | 2025-07-18 CUSTOM PACK BB5N65R17 OSU E |
| 00199150033553 - NA | 2025-07-18 CUSTOM PACK BB12Q62R NORTON HEALTH |