Primary Device ID | 00062790810054 |
NIH Device Record Key | 0135ef35-2d66-419e-bf12-48a36df20b33 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integrity EP Headphones |
Version Model Number | HDA 300 |
Company DUNS | 201740425 |
Company Name | Vivosonic Inc |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00062790810054 [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 | 2016-09-23 |
00062790820107 | TDH EP headphones for use as an accessory with the second generation Integrity V500 system (DI: |
00062790820091 | HDA-300 EP headphones for use as an accessory with the second generation Integrity V500 system ( |
00062790810054 | HDA-300 EP headphones for use as an accessory with the first generation Integrity V500 system (D |
00627908020109 | TDH EP headphones for use as an accessory with the second generation Integrity V500 system (DI: |
00627908020093 | HDA-300 EP headphones for use as an accessory with the second generation Integrity V500 system ( |
00627908010056 | HDA-300 EP headphones for use as an accessory with the first generation Integrity V500 system (D |