WavelyDx Middle Ear Fluid CMD iOS Application SWA-1262

GUDID 00860007953712

The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. 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.

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• Primary Device ID: 00860007953712
• NIH Device Record Key: 4ef96093-a1fc-4c96-b892-ea0530e2d2a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WavelyDx Middle Ear Fluid CMD iOS Application
• Version Model Number: SWA-1262
• Catalog Number: SWA-1262
• Company DUNS: 116723050
• Company Name: Wavely Diagnostics, Inc.
• Device Count: 1
• 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: false
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007953712 [Primary]

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: 2022-08-16 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: 2022-08-16The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. 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.
• 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