| Primary Device ID | 00382830007467 |
| NIH Device Record Key | f67f7613-7363-41e1-9807-c7ecedcfd044 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Olympic Brainz Monitor |
| Version Model Number | Neonatal Sensors |
| Catalog Number | OBM00042 |
| Company DUNS | 962519208 |
| Company Name | NATUS MEDICAL INCORPORATED |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00382830007467 [Primary] |
| OMC | Reduced- Montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-12-29 |
| 00382830050517 - NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET | 2024-11-08 NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET |
| 00382830050524 - NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER | 2024-11-08 NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER |
| 00382830050531 - NATUS LUMBAR CATHETER KIT | 2024-11-08 NATUS LUMBAR CATHETER KIT |
| 00382830050548 - NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER | 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER |
| 00382830050555 - NATUS EDS3 DRAINAGE SYSTEM | 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM |
| 00382830050562 - NATUS EDS3 COLLECT BAG KIT 5 BAGS | 2024-11-08 NATUS EDS3 COLLECT BAG KIT 5 BAGS |
| 00382830050579 - NATUS EDS3 LEVELING DEVICE | 2024-11-08 NATUS EDS3 LEVELING DEVICE |
| 00382830050593 - NATUS EDS3 LUMBAR CATHETER KIT | 2024-11-08 NATUS EDS3 LUMBAR CATHETER KIT |