No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05713315009266 | 8-04-13330 | AirCal Caloric Stimulator, Extended (Extended length - 4m) | KHH | Stimulator, Caloric-Air | 1 | ICS | |
2 | 05713315009235 | 8-04-13300 | AirCal Caloric Stimulator (Standard length - 3m) | KHH | Stimulator, Caloric-Air | 1 | ICS | |
3 | 05713315009259 | 8-04-13320 | AirCal Caloric Stimulator, Extended (Extended length - 4m) | KHH | Stimulator, Caloric-Air | 1 | ICS | |
4 | 05713315009242 | 8-04-13301 | AirCal Caloric Stimulator, Extended (Extended length - 4m) | KHH | Stimulator, Caloric-Air | 1 | ICS | |
5 | 05713315008788 | Preamp Lanyard, EP 200 | 8-66-99500 | Preamp Lanyard for ICS Chartr EP 200 | GWJ | Stimulator, Auditory, Evoked Response | 2 | ICS |
6 | 05713315008771 | Preamp Shoulder Harness, EP 200 | 8-66-99400 | Preamp Shoulder Harness for ICS Chartr EP 200 | GWJ | Stimulator, Auditory, Evoked Response | 2 | ICS |
7 | 05713315008764 | Chartr EP 200 Starter Kit | 8-69-40700 | Starter Kit for ICS Chartr EP 200 | GWJ | Stimulator, Auditory, Evoked Response | 2 | ICS |
8 | 05713315008757 | LOOP BACK TESTER, EP 200 | 8-40-00800 | Loop Back Tester for ICS Chartr EP 200 | GWJ | Stimulator, Auditory, Evoked Response | 2 | ICS |
9 | 05713315008740 | 1073, Main U Chartr EP Pre-Amp | 8-35-29600 | Pre-Amp for ICS Chartr EP 200 | GWJ | Stimulator, Auditory, Evoked Response | 2 | ICS |
10 | 05713315008474 | 1085, FACE CUSHION 2 ASM KIT | 8-35-50100 | GWN | Nystagmograph | 2 | Otometrics | |
11 | 05713315009013 | 1012 OTOflex Cavity set | 8-67-41300 | Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100 | ETY | Tester, Auditory Impedance | 2 | Madsen |
12 | 05713315000539 | Small Tip Kit | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
13 | 05713315000126 | Elevation plate | ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | GN Otometrics A/S | ||
14 | 05713315005633 | 1096,SA, DIAG W/O PRIN,COM US | 8-04-16044 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
15 | 05713315005626 | 1096,SA, DIAG W/ PRIN,CLASS US | 8-04-16043 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
16 | 05713315005619 | 1096,SA, DIAG W/ PRIN, COM US | 8-04-16042 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
17 | 05713315005602 | 1096,SA, QUICKCHECK W/ PRIN, US | 8-04-16041 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
18 | 05713315005596 | 1096,SA, QUICKCHECK W/O PRIN, US | 8-04-16040 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
19 | 05713315005664 | 1096, SA CLINI W/ PRIN,COM US | 8-04-16047 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
20 | 05713315005657 | 1096, SA,CLINI W/ PRIN, CLAS US | 8-04-16046 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
21 | 05713315005640 | 1096, SA,DIAG W/O PRIN,CLASS US | 8-04-16045 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
22 | 05713315004445 | Headset ME70 (8 kHz) | EWO | Audiometer | 2 | GN Otometrics A/S | ||
23 | 05713315005558 | 1096, PC, DIAGNOSTIC, COM, US | 8-04-16031 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | |
24 | 05713315005176 | 1096, CONTRA TDH39 | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | ||
25 | 05713315004698 | Probe tip for TEOAE (pack of 5 pcs) | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
26 | 05713315004629 | Headset Holmco (95-01) | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | ||
27 | 05713315004667 | "AccuScreen Starter Kit | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
28 | 05713315004636 | "Headset HB-7 (8 kHz) matched | ETY | Tester, Auditory Impedance | 2 | GN Otometrics A/S | ||
29 | 05713315004605 | Sound Booth Installation Kit | EWO | Audiometer | 2 | GN Otometrics A/S | ||
30 | 05713315004582 | "TO/TB monitoring system | EWO | Audiometer | 2 | GN Otometrics A/S | ||
31 | 05713315004568 | "Headset Monitoring w/ boom mic | EWO | Audiometer | 2 | GN Otometrics A/S | ||
32 | 05713315000416 | Eartip 6-9 mm Blue Tree (Bag of 250 pcs.) | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
33 | 05713315000386 | Eartip 5 mm Blue (Bag of 50) | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
34 | 05713315000379 | External Battery Charger | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
35 | 05713315000140 | Battery Probe Hit | ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | GN Otometrics A/S | ||
36 | 05713315000133 | Ear 2 Ear Verification | ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | GN Otometrics A/S | ||
37 | 05713315004193 | ABR Electrode Cable | GWJ | Stimulator, Auditory, Evoked Response | 2 | GN Otometrics A/S | ||
38 | 05713315008467 | 1085, FACE PAD ASSEMBLY KIT V2 | 8-35-39300 | GWN | Nystagmograph | Otometrics | ||
39 | 05713315008443 | 1085, STRAP ASSEMBLY | 8-35-34200 | GWN | Nystagmograph | 2 | Otometrics | |
40 | 05713315009228 | 8-04-14562-CA | Madsen A450 audiometer | EWO | Audiometer | 2 | Madsen | |
41 | 05713315009204 | 8-04-13102-CA | Madsen Astera2 clinical audiometer | EWO | Audiometer | 2 | Madsen | |
42 | 05713315008412 | Torsional Module | 8-69-42634 | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
43 | 05713315008405 | Monocular Positional | 8-69-42633 | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
44 | 05713315008399 | LARP/RALP Head Impulse | 8-69-42632 | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
45 | 05713315008382 | Lateral Head Impulse | 8-69-42631 | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
46 | 05713315008375 | Monocular Oculomotor Limited | 8-69-42630 | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
47 | 05713315005961 | Madsen A450 | With inserts | EWO | Audiometer | 2 | Otometrics | |
48 | 05713315008368 | ICS Monocular VNG Video/oculd/Posit kit (US Version) | 8-62-52700-US | GWN | Nystagmograph | 2 | GN Otometrics A/S | |
49 | 05713315008252 | Insert Earphone Tube Tips | EWO | Audiometer | 2 | GN Otometrics A/S | ||
50 | 05713315008184 | OTOair 2 Bluetooth Dongle | ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | GN Otometrics A/S |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00643169861459 | 945NCCPULO | COMPUTER 945NCCPULO LOANER NOTEBOOK | NIM Eclipse | MEDTRONIC XOMED, INC. | |
2 | 00643169793880 | 945OPM660LO | MODULE 945OPM660LO LOANER PATIENT | NIM Eclipse | MEDTRONIC XOMED, INC. | |
3 | 00643169793866 | 945EEX901LO | STIMULATOR 945EEX901LO LOANER EXTENDER | NIM Eclipse | MEDTRONIC XOMED, INC. | |
4 | 00643169793859 | 945ECLCLO | CONTROLLER 945ECLCLO LOANER ECLIPSE | NIM Eclipse | MEDTRONIC XOMED, INC. | |
5 | 00643169793842 | 945DAQ916LO | PREAMPLIFIER 945DAQ916LO LOANER DIGITAL | NIM Eclipse | MEDTRONIC XOMED, INC. | |
6 | 00643169786653 | ECLC | CONTROLLER ECLC ECLIPSE ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
7 | 00643169553071 | 945NCCPULO | COMPUTER 945NCCPULO LOANER NOTEBOOK | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
8 | 00643169553057 | 945OPM660LO | MODULE 945OPM660LO LOANER PATIENT | NA | MEDTRONIC XOMED, INC. | |
9 | 00643169553040 | 945EEX901LO | STIMULATOR 945EEX901LO LOANER EXTENDER | NA | MEDTRONIC XOMED, INC. | |
10 | 00643169553033 | 945ECLCLO | CONTROLLER 945ECLCLO LOANER ECLIPSE | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
11 | 00643169553026 | 945DAQ916LO | PREAMPLIFIER 945DAQ916LO LOANER DIGITAL | NA | MEDTRONIC XOMED, INC. | |
12 | 00643169523548 | 945CUSB100 | CABLE 945CUSB100 CONTROLLER USB JUMPER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
13 | 00643169468573 | NCCPU | COMPUTER NCCPU NOTEBOOK E6540 ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
14 | 00643169378490 | MDP201 | PROBE MDP201 MUTE DETECTOR ROHS | NA | MEDTRONIC XOMED, INC. | |
15 | 00643169378483 | EEX901 | STIMULATOR EEX901 EXTENDER ROHS | NA | MEDTRONIC XOMED, INC. | |
16 | 00643169378476 | DAQ916 | PREAMPLIFIER DAQ916 DIGITAL ROHS | NA | MEDTRONIC XOMED, INC. | |
17 | 00643169378469 | ECLC | CONTROLLER ECLC ECLIPSE ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
18 | 00643169378452 | SPK1004 | PROBE SPK1004 SURGEON CONTROLLED ROHS | NA | MEDTRONIC XOMED, INC. | |
19 | 00643169246003 | 945SYSLO | LOANER SYSTEM 945SYSLO NIM ECLIPSE | NIM-ECLIPSE | MEDTRONIC XOMED, INC. | |
20 | 00643169221000 | NWCPU | COMPUTER NWCPU DESKTOP ENGLISH ROHS | NIM-Eclipse® | MEDTRONIC XOMED, INC. | |
21 | 00643169177710 | NCCPU | COMPUTER NCCPU NOTEBOOK ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
22 | 00643169072053 | 945CUSB100 | CABLE 945CUSB100 CONTROLLER USB JUMPER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
23 | 00643169071933 | 945DAQ916 | AMPLIFIER 945DAQ916 DIG PREAMPLIFIER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
24 | 00643169071773 | 945AE102 | EARPHONES 945AE102 INSERT | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
25 | 00643169071759 | 945CDAQ916 | CABLE 945CDAQ916 PREAMPLIFIER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
26 | 00643169071742 | 945CEEX20 | CABLE 945CEEX20 20FT STIMULATOR | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
27 | 00643169071735 | 945CEEX98 | CABLE 945CEEX98 8FT STIMULATOR | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
28 | 00643169071711 | 945CNCPS101 | CABLE 945CNCPS101 COMP AC JUMPER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
29 | 00643169071704 | 945CPC16 | CORD 945CPC16 HOSP GRADE LINE | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
30 | 00643169020337 | 945CEEX20LO | CABLE 945CEEX20LO LOANER 20FT STIMULATOR | NA | MEDTRONIC XOMED, INC. | |
31 | 00643169020269 | 945DAQ916LO | PREAMPLIFIER 945DAQ916LO LOANER DIGITAL | NA | MEDTRONIC XOMED, INC. | |
32 | 00643169020252 | 945ECLCLO | CONTROLLER 945ECLCLO LOANER ECLIPSE | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
33 | 00643169020245 | 945EEX901LO | STIMULATOR 945EEX901LO LOANER EXTENDER | NA | MEDTRONIC XOMED, INC. | |
34 | 00643169020191 | 945NCCPULO | COMPUTER 945NCCPULO LOANER NOTEBOOK | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
35 | 00643169020177 | 945OPM660LO | MODULE 945OPM660LO LOANER PATIENT | NA | MEDTRONIC XOMED, INC. | |
36 | 00627908090027 | SWA002 | Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for s 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 | Aurix Software | VIVOSONIC INC | |
37 | 00627908090010 | SWA001 | Integrity software for use with the first generation Integrity V500 system (DI: 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 | Integrity Software | VIVOSONIC INC | |
38 | 00627908080097 | WA021 | Tablet for use with the Aurix system (DI: 00627908080011). The UDI is compris 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) | Aurix Tablet Computer | VIVOSONIC INC | |
39 | 00627908080080 | 100004 | Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is compris Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) | Aurix Ear Domes | VIVOSONIC INC | |
40 | 00627908080073 | 100001 | Electrodes for use with the Aurix system (DI: 00627908080011). The UDI is comp Electrodes for use with the Aurix system (DI: 00627908080011). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) | Aurix Electrodes | VIVOSONIC INC | |
41 | 00627908080066 | ER-3A-AUX | ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627 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) | Aurix Insert Earphones | VIVOSONIC INC | |
42 | 00627908080059 | 100116 | Lead cable for use with the Aurix Amplifier (DI: 00627908080035) as an accessory 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) | Aurix Amplifier Lead Cable | VIVOSONIC INC | |
43 | 00627908080042 | 11010 | Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is com 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) | Aurix Laptop Computer | VIVOSONIC INC | |
44 | 00627908080035 | 11003 | Amplifier for use with the Aurix system (DI: 00627908080011).The UDI is compris 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) | Aurix Amplifier | VIVOSONIC INC | |
45 | 00627908080028 | 11002 | Sound stimulator for use with the Aurix system (DI: 00627908080011).The UDI is c 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) | Aurix Sound Stimulator | VIVOSONIC INC | |
46 | 00627908080011 | AURIX-1 | Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN 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 | Aurix Newborn Hearing Screening System | VIVOSONIC INC | |
47 | 00627908070074 | 100004 | EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI i EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) | EarDome | VIVOSONIC INC | |
48 | 00627908070067 | 100001 | Electrodes for use with the Integrity system (DI: 00627908020017).The UDI is c Electrodes for use with the Integrity system (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) | VivoTab Electrode (4 pack) | VIVOSONIC INC | |
49 | 00627908070050 | 100001 | Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 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) | VivoTab Electrode (3 pack) | VIVOSONIC INC | |
50 | 00627908020154 | ST-800 | Sound stimulator for use as an accessory with the second generation Integrity V5 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). | Integrity VivoStim | VIVOSONIC INC |