Primary Device ID | 00382830001595 |
NIH Device Record Key | 5f9152c0-58fd-49ff-b354-3f17d07cc50e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AuDX Pro Otoacoustic Emissions Measurement System |
Version Model Number | AuDX Pro |
Catalog Number | 580-AXPRO1 |
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 |
Phone | 1-800-303-0306 |
Technical_service@natus.com | |
Phone | 1-800-303-0306 |
Technical_service@natus.com |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00382830001595 [Primary] |
EWO | Audiometer |
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 | 2017-09-11 |
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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 |
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