ClearWaves

GUDID 10810113578184

Hearing Aids (Empower)

VIVE HEALTH LLC

Air-conduction hearing aid, receiver-in-the-ear

• Primary Device ID: 10810113578184
• NIH Device Record Key: 5ff81da3-2545-4378-8725-a6ba2a763ee3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearWaves
• Version Model Number: LVA3072BGE
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113578187 [Primary]
GS1	10810113578184 [Package]; Contains: 00810113578187; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

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: 2024-09-23
• Device Publish Date: 2024-09-13

On-Brand Devices [ClearWaves]

• 10810113578191: Hearing Aids (Essential)
• 10810113578184: Hearing Aids (Empower)
• 10810113578177: Hearing Aids (Advanced)