ABR Infection Control Sleeve

GUDID 05060396170638

OTODYNAMICS LIMITED

Evoked-potential audiometer

• Primary Device ID: 05060396170638
• NIH Device Record Key: 1ed7c7ae-010f-400f-9116-d31c0d33f73f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABR Infection Control Sleeve
• Version Model Number: ABR-INF
• Company DUNS: 235908050
• Company Name: OTODYNAMICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05060396170638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143395

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-11

Devices Manufactured by OTODYNAMICS LIMITED

• 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: 2024-08-28 OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)