Primary Device ID | 00382830053297 |
NIH Device Record Key | be3253a5-b82b-4932-91b4-b514f0d54fe0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ALGO 3i Newborn Hearing Screener |
Version Model Number | Algo 3i |
Catalog Number | 040695, 040969 |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 38 Degrees Celsius |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit |