| Primary Device ID | 00681490132558 |
| NIH Device Record Key | ad15df77-f23d-45b8-ba8c-1042dd9b2502 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5437 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490132558 [Primary] |
| DXY | implantable pacemaker Pulse-generator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
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| 00763000993924 - NA | 2025-01-28 CUSTOM PACK BB10Y59R12 FUSION |
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| 08033477072012 - Pacific™ Plus | 2025-01-28 CATH PCP060300090 PLUS US D6L300UL900 |
| 08033477072029 - Pacific™ Plus | 2025-01-28 CATH PCP060300150 PLUS US D6L300UL1500 |