| Primary Device ID | 00613994334749 |
| NIH Device Record Key | 1b3c7d3a-e7ce-4265-83dd-89a2b90fa96f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 11-0401-CA |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, 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 | 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 | 00613994334749 [Primary] |
| JXG | Shunt, central nervous system and components |
| 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 | 2015-06-24 |
| 00763000467364 - BECKER SYSTEMS | 2024-07-01 EDMS 27931 BECKER GS TUBING SMARTSITES |
| 00763000467401 - NA | 2024-06-10 CONNECTOR 9041 LUERLOCK TO FIT 1.3MM ID |
| 00763000529338 - Becker External Drainage and Monitoring System | 2024-05-27 BECKER 27761 STOP BCNDLESS PATLN 24 |
| 00763000406073 - Becker | 2024-04-08 EDMS 46128 BECKER II BLUE PT LN |
| 00763000467340 - NA | 2024-03-11 KIT 46442 EDM LUMBAR DRN CLS TIP 5PK |
| 00763000406042 - NA | 2024-03-05 ASSEMBLY 46422 EDM DRAINAGE |
| 00763000406080 - NA | 2024-03-05 DRAIN 27302 EDM LUMBAR W/120 GRAD CH |
| 00763000431259 - Becker | 2024-03-05 EDMS 46129 EURO BECKER II BLUE PT LN |