Wavely Ear Tip 1300-05

GUDID 00860007953705

The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.

Wavely Diagnostics, Inc.

Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer

• Primary Device ID: 00860007953705
• NIH Device Record Key: 67fef44f-0ab7-4ea9-bf7b-e30bcf1f6d8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wavely Ear Tip
• Version Model Number: 1300-05
• Catalog Number: 1300-05
• Company DUNS: 116723050
• Company Name: Wavely Diagnostics, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007953705 [Primary]
GS1	00860007953798 [Unit of Use]

FDA Product Code

• PTO: Tester, Auditory Impedance, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

Devices Manufactured by Wavely Diagnostics, Inc.

• 00860007953705 - Wavely Ear Tip: 2022-08-16The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
• 00860007953705 - Wavely Ear Tip: 2022-08-16 The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely Middle Ear Fluid Scanner turns a smartpho
• 00860007953712 - WavelyDx Middle Ear Fluid CMD iOS Application: 2022-08-16 The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in con