| Primary Device ID | 00763000210212 |
| NIH Device Record Key | bfa61527-c141-4729-9ca4-196b7cbbd779 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DB-5000 |
| Company DUNS | 796986144 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000210212 [Unit of Use] |
| GS1 | 20763000210216 [Primary] |
| GXR | COVER, BURR HOLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-10-24 |
| 00199150006434 - NA | 2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V |
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| 20199150006919 - NA | 2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y |
| 00199150006922 - NA | 2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD |