OtoNova Battery Assembly Service Kit

GUDID 05060396172809

Otoacoustic emission system, battery-powered

Primary Device ID	05060396172809
NIH Device Record Key	4603a2c1-5cc4-4bcf-8ca3-ce700d6b94d3
Commercial Distribution Status	In Commercial Distribution
Brand Name	OtoNova Battery Assembly Service Kit
Version Model Number	ON-BATT-KIT
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	true
Serial Number	false
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	05060396172809 [Primary]

EWO	Audiometer

Steralize Prior To Use	false
Device Is Sterile	false

05060396171130 - Crib/bassinet device holster for OtoNova	2024-08-28 Crib/bassinet device holster for OtoNova
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	2024-08-28OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)
05060396172809 - OtoNova Battery Assembly Service Kit	2024-08-28 OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)