| Primary Device ID | 00763000004989 |
| NIH Device Record Key | db269cae-546f-4df4-99a1-9eb5ef2088c8 |
| 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 | 00763000004989 [Primary] |
| GS1 | 70763000004988 [Unit of Use] |
| 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 | 2019-05-21 |
| Device Publish Date | 2019-05-13 |
| 00199150030842 - NA | 2025-07-15 CUSTOM PACK BB8B05R17 HBC |
| 00199150026654 - NA | 2025-07-07 CUSTOM PACK BB11E82R2 CB E SUPP |
| 00199150026661 - NA | 2025-07-07 CUSTOM PACK BB7D23R7 RADL |
| 00199150026722 - NA | 2025-07-07 CUSTOM PACK BB8T30R14 3/8 COMER |
| 00199150026739 - NA | 2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT |
| 20199150026887 - NA | 2025-07-07 CUSTOM PACK BB8M18R1 2PK 1/4 LINES |
| 00199150026890 - NA | 2025-07-07 CUSTOM PACK BB6U14R7 TABLE PK |
| 00199150026906 - NA | 2025-07-07 CUSTOM PACK BB11S65R3 UAB L U N G T |