| Primary Device ID | 20643169120185 |
| NIH Device Record Key | ae98e496-5806-44e4-a9d2-37c0a452b2f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DLP7H29R |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 5 |
| 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 | 00643169120181 [Unit of Use] |
| GS1 | 20643169120185 [Primary] |
| 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 | 2016-06-05 |
| 20763000394091 - DxTerity™ | 2025-01-28 DXT6JL45X DXT 6F 5PK 125CM JL45 |
| 20763000395180 - DxTerity™ TRA | 2025-01-28 CATH U5ULTRA35 DXT 5F 5PK 100CM UL35 |
| 00763000993924 - NA | 2025-01-28 CUSTOM PACK BB10Y59R12 FUSION |
| 00763000993931 - NA | 2025-01-28 CUSTOM PACK BB7M46R26 SCV ADLT |
| 00763000993948 - NA | 2025-01-28 CUSTOM PACK BB11U59R5 BYPASS TUBING |
| 00763000993955 - NA | 2025-01-28 CUSTOM PACK BB8M65R3 RIDEOUT |
| 08033477072012 - Pacific™ Plus | 2025-01-28 CATH PCP060300090 PLUS US D6L300UL900 |
| 08033477072029 - Pacific™ Plus | 2025-01-28 CATH PCP060300150 PLUS US D6L300UL1500 |