Healthisound

GUDID 00860013064044

Enticare P.C.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00860013064044
• NIH Device Record Key: 1f4f44e9-4c99-45a1-9c9a-040e5008d066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthisound
• Version Model Number: JH-A17BT
• Company DUNS: 932173037
• Company Name: Enticare P.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013064044 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, 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: 2024-12-05
• Device Publish Date: 2024-11-27