Primary Device ID | 05060396173363 |
NIH Device Record Key | 4fb5ddb0-75d3-4bb9-b0f1-3524f8d091f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Otoport Charger V2 |
Version Model Number | OPRO-CHG |
Company DUNS | 235908050 |
Company Name | OTODYNAMICS LIMITED |
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 | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com | |
Phone | 1-800-659-7776 |
info@otodynamics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05060396173363 [Primary] |
EWO | Audiometer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-25 |
Device Publish Date | 2024-07-17 |
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05060396171512 - Tablet Computer for OtoNova Pro | 2024-08-28 Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requi |
05060396171529 - OtoNova Charger | 2024-08-28 Medical Power Supply Unit for OtoNova Wireless Charging Pad |
05060396171536 - OtoNova Wireless Charging Pad | 2024-08-28 Wireless Charging Pad for OtoNova/OtoNova Pro. WPC (Qi) specification v1.2 |
05060396172243 - XPD Ear Probe | 2024-08-28 Next generation 'X-series' general purpose ear probe for TEOAE and DPOAE hearing screening/analysis, auditory stimulus for AABR; |
05060396172359 - ABR Electrode Cable (SNAP) for OtoNova Pro | 2024-08-28 ABR electrode cable for use with 4mm SNAP electrodes, length 44"/1.1M, Red/Black/White color coding, straight 4-pin yellow plug, |
05060396172366 - ABR Electrode Cable (TAB) for OtoNova Pro | 2024-08-28 ABR electrode cable for use with TAB electrodes, length 44"/1.1M, Red/Black/White color coding, straight yellow 4-pin plug, for |
05060396172809 - OtoNova Battery Assembly Service Kit | 2024-08-28 OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only) |