Lexie Hearing 93237-004

GUDID 00858177007595

Hearing Aid Accessory

INTRICON CORPORATION

Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia Hearing aid enhanced audio device, telecommunication/multimedia

• Primary Device ID: 00858177007595
• NIH Device Record Key: b3021f2e-6101-4e6b-8a3f-6f2a596581ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lexie Hearing
• Version Model Number: CM1
• Catalog Number: 93237-004
• Company DUNS: 002345767
• Company Name: INTRICON CORPORATION
• 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: false
• Serial Number: true
• 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: true

Customer Support Contacts

• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858177007595 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

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: 2020-10-26
• Device Publish Date: 2020-10-16

On-Brand Devices [Lexie Hearing]

• 00858177007540: BTE Wireless Hearing Aid, Lumen 155i, Light Grey
• 00858177007533: BTEar Wireless Hearing Aid, Lumen 155i, Beige
• 00858177007526: BTE Wireless Hearing Aid, Lumen 155i, Metallic Black
• 00858177007519: BTE Wireless Hearing Aid, Lumen 155i, Bronze
• 00858177007595: Hearing Aid Accessory