Integrity V500 (Integrity, Integrity with VEMP)
Vivosonic, Inc.
Vivosonic, Inc.
PMN#
VIVOSONIC NEUROSCREEN
VIVOSONIC, INC.
INTEGRITY, MODEL V500
VIVOSONIC, INC.
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
VIVOSONIC, INC.
VIVO 200 DPS VIVOSCAN
VIVOSONIC, INC.
GUDID#
Bone Conductor - B81
2023-06-12
EP Headphones - H-802
2023-06-08
ECochG Adapters - E-110
2023-06-08
Integrity VivoStim - Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2020-05-04
Integrity V500 - Main handheld VivoLink unit for use with the first generation Integrity V500 system.The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following are accessories that can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025B71-10 Bone Conductor: DI 00627908010032ER-3A-ABR Insert Earphones: DI 00627908010049HDA 300 EP Headphones: DI 00627908010056P40-GP OAE Probe: DI 00627908010063P40-UG OAE Probe: DI 00627908010070
2016-09-23
Integrity Amplitrode - One channel Amplitrode for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity Bone Conductor - Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity Insert Earphones - ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity EP Headphones - HDA-300 EP headphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity OAE Probe - GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity OAE Probe - UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity V500 - Main handheld VivoLink unit for use with second generation Integrity V500 system.The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024A82 Amplitrode: DI 00627908020031A90 VivoAmp: DI 00627908020048B71W Bone Conductor: DI 00627908020055ER-2-800 Insert Earphones: DI 00627908020062ER-3A-800 Insert Earphones: DI 00627908020079ER-3C-800 Insert Earphones: DI 00627908020086H-800 EP Headphones: DI 00627908020093H-801 EP Headphones: DI 00627908020109P81-GP OAE Probe: DI 00627908020116P81-UG OAE Probe: DI 00627908020123Computer: DI 00627908020130
2016-09-23
Integrity Amplitrode - One channel Amplitrode for use as an accessory with the second generation of the Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity Amplitrode - Dual channel Amplitrode for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity VivoAmp - Dual channel VivoAmp for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017)The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity Bone Conductor - Bone conductor for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity Insert Earphones - ER-2 insert earphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity Insert Earphones - ER-3A insert earphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity Insert Earphones - ER-3C insert earphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity EP Headphones - HDA-300 EP headphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity EP Headphones - TDH EP headphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity OAE Probe - GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017) The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity OAE Probe - UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
2016-09-23
Integrity Computer - Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity CV-Amp - Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017)The UDI is comprised of GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2019-03-20
VivoTab Electrode (3 pack) - Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2017-10-05
VivoTab Electrode (4 pack) - Electrodes for use with the Integrity system (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2019-10-29
EarDome - EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2019-10-29
Aurix Newborn Hearing Screening System - Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 0062790808002811003 Amplifier DI: 0062790808003511010 Laptop Computer DI: 00627908080042100116 Amplifier Lead Cable DI: 00627908080059ER-3A-AUX Insert Earphones DI:00627908080066100001 Electrodes DI: 00627908070067100004 Ear Domes DI: 00627908080080WA021 Tablet Computer DI: 00627908080097
2016-09-23
Aurix Sound Stimulator - Sound stimulator for use with the Aurix system (DI: 00627908080011).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Aurix Amplifier - Amplifier for use with the Aurix system (DI: 00627908080011).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Aurix Laptop Computer - Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Aurix Amplifier Lead Cable - Lead cable for use with the Aurix Amplifier (DI: 00627908080035) as an accessory to the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Aurix Insert Earphones - ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Aurix Electrodes - Electrodes for use with the Aurix system (DI: 00627908080011). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2016-09-23
Aurix Ear Domes - Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2016-09-23
Aurix Tablet Computer - Tablet for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
2016-09-23
Integrity Software - Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
2016-09-23
Aurix Software - Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
2016-09-23
VivoTab Electrode (4 pack) - Electrodes for use with the Integrity system (DI: 00062790820015). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
2019-10-29