| Primary Device ID | 20613994648314 |
| NIH Device Record Key | 6703a5fb-d664-45e1-a45c-20304ac35f68 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DLP3P16R4 |
| 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 | 00613994648310 [Primary] |
| GS1 | 20613994648314 [Package] Contains: 00613994648310 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 |
| 00199150050161 - NA | 2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK |
| 00199150050178 - NA | 2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E |
| 00199150050185 - NA | 2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L |
| 20199150050202 - NA | 2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK |
| 00199150050871 - NA | 2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4 |
| 00763000877033 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15006X SPR LEG RX US M |
| 00763000877040 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15010X SPR LEG RX US M |
| 00763000877057 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15012X SPR LEG RX US M |