OXILINE

GUDID 16971094538094

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 16971094538094
• NIH Device Record Key: ec4a1ce8-0ca3-4576-9b7d-de446b41b4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXILINE
• Version Model Number: JH-DW3F
• Company DUNS: 547508199
• Company Name: Huizhou Jinghao Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	06971094538097 [Primary]
GS1	16971094538094 [Package]; Contains: 06971094538097; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221052

FDA Product Code

• QUH: Self-Fitting Air-Conduction Hearing Aid, 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: 2025-04-01
• Device Publish Date: 2025-03-24

On-Brand Devices [OXILINE]

• 16971094538094: JH-DW3F
• 16971094538087: JH-DW2ET