| Primary Device ID | 00382830000727 |
| NIH Device Record Key | cc9e1fba-b83a-48e0-a888-9788036ff22e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATUS MEDICAL |
| Version Model Number | 203200 |
| 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 | false |
| 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 |
| Technical.Service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical.Service@natus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830000727 [Primary] |
| 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-26 |
| 00382830044738 | PCA Electrode Cable for Echo-Screen III Devices |
| 00382830044721 | ATA Transducer for Echo-Screen III Devices |
| 00382830044660 | Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set w/o Barcode Scanner |
| 00382830044653 | Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set |
| 00382830044646 | Echo-Screen III Pro Hearing Screening Device DPOAE and ABR set w/o Barcode Scanner |
| 00382830044639 | Echo-Screen III Pro Hearing Screening Device DPOAE and ABR set |
| 00382830044622 | Echo-Screen III Pro Hearing Screening Device TEOAE and ABR set w/o Barcode Scanner |
| 00382830044615 | Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set |
| 00382830044608 | Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set w/o Barcode Scanner |
| 00382830044592 | Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set |
| 00382830044585 | Echo-Screen III Pro Hearing Screening Device ABR set w/o Barcode Scanner |
| 00382830044578 | Echo-Screen III Pro Hearing Screening Device ABR set |
| 00382830044561 | Echo-Screen III Pro Hearing Screening Device DPOAE set w/o Barcode Scanner |
| 00382830044554 | Echo-Screen III Pro Hearing Screening Device DPOAE set |
| 00382830044547 | Echo-Screen III Pro Hearing Screening Device TEOAE set w/o Barcode Scanner |
| 00382830044530 | Echo-Screen III Pro Hearing Screening Device - TEOAE set with Barcode Scanner |
| 00382830044066 | ALGO 3i Patient Connection Assembly (PCA) Long Cable |
| 00382830044059 | Preamplifier 3 Cable |
| 00382830044042 | Patient Cable Assembly (PCA) Cable |
| 00382830044035 | ALGO 3i Acoustic Transducer Assembly (ATA) Cable |
| 00382830044028 | ALGO 3i Preamplifier, Short Length |
| 00382830043977 | ALGO 5 Pre-Amplifier Cable |
| 00382830043960 | ALGO 5 Patient Cable Assembly (PCA) Cable |
| 00382830043915 | ALGO 5 US ACCESSORY BOX |
| 00382830000727 | OAE Jumbo Ear Tips - qty 20 |