AcoSound

GUDID 06973375880376

Hangzhou AcoSound Technology Co.,Ltd.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 06973375880376
• NIH Device Record Key: c9e9f3ce-ce58-418d-a725-b94f7a1ff7d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcoSound
• Version Model Number: Leya-BTE-P
• Company DUNS: 542986440
• Company Name: Hangzhou AcoSound Technology Co.,Ltd.
• 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: 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	06973375880376 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2022-11-17
• Device Publish Date: 2022-11-09

On-Brand Devices [AcoSound]

• 06973375880147: Chargable, Rechargeable ear canal digital hearing aid,
• 06973375880130: NP-BTE-M
• 06973375880123: NP-IF2
• 06973375880116: M-10
• 06973375880109: NP-IF1
• 06973375880093: A-1-G
• 06973375880086: W12-BTE-M
• 06973375880079: W12-IF-P
• 06973375880062: W8-BTE-M
• 06973375880055: W8-IF-P
• 06973375880048: W4-BTE-M
• 06973375880031: W4-IF-P
• 06973375880024: LW4-BTE-M-N
• 06973375880017: LW4-IF-P-N
• 06973375880178: Celesto-W-BTE-P
• 06973375880161: Celesto-W-BTE-M
• 06973375880154: Leya-W-BTE-P
• 06973375880000: Leya-W- BTE-M
• 06973375880390: Celesto-BTE-P
• 06973375880383: Celesto-BTE-H
• 06973375880376: Leya-BTE-P
• 06973375880369: Leya-BTE-H
• 06973375880567: Leya-W-RIC-S
• 06973375880550: Leya-W-IF-P
• 06973375880543: Celesto-BTE-M
• 06973375880536: Celesto-RIC-M
• 06973375880529: Celesto-RIC-S
• 06973375880512: Celesto-IF-P
• 06973375880505: Celesto-IF
• 06973375880499: Leya-BTE-P-N
• 06973375880482: Leya-BTE-M-N
• 06973375880475: Leya-BTE-M
• 06973375880468: Leya-RIC-M
• 06973375880451: Leya-RIC-S-N
• 06973375880444: Leya-RIC-S
• 06973375880437: Leya-IF-P-N
• 06973375880420: Leya-IF-P
• 06973375880413: Leya-IF-N
• 06973375880406: Leya-IF
• 06973375880734: TW-RIC-C
• 06973375880727: TW-RIC-M
• 06973375880765: TW-IF-P
• 06973375880710: SonarPro
• 06973375883025: TW-IF-C
• 06973375883148: TW-RIC-C(right)
• 06973375883131: TW-RIC-C(left)
• 06973375883124: Leya-W- BTE-M
• 06973375883117: Leya-W- BTE-M(1 pair)
• 06973375883193: Leya-ITC
• 06973375883353: TW-IF-C R