| Primary Device ID | 00382830051231 |
| NIH Device Record Key | 7cab5d27-03b0-43ec-8940-746a25afd6c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Echo-Screen Hearing Screening Supplies |
| Version Model Number | Echo-PAK |
| Catalog Number | 1630-25-US |
| Company DUNS | 962519208 |
| Company Name | NATUS MEDICAL INCORPORATED |
| Device Count | 50 |
| 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 |
| Phone | 1-800-303-0306 |
| BLSC_Hearing_Support@natus.com | |
| Phone | 1-800-303-0306 |
| BLSC_Hearing_Support@natus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830051231 [Primary] |
| GS1 | 00382830053266 [Unit of Use] |
| GWJ | Stimulator, Auditory, Evoked Response |
| 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 | 2017-01-06 |
| 00382830062190 - Natus | 2024-03-20 Intracranial Pressure and Temperature Monitor |
| 10382830062289 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10382830062296 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10382830062302 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10382830062319 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10382830062326 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10382830062333 - Natus | 2023-05-12 CRANIAL ACCESS KIT |
| 10381780039310 - CAMINO® | 2020-05-06 Intracranial Pressure and Temperature Monitor |