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GUDID 16977239080053

ShenZhen GoodlyMed Technology Co.,Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16977239080053
• NIH Device Record Key: c23112df-6b94-47ed-9890-d427b24c2b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: /
• Version Model Number: A01
• Company DUNS: 699346365
• Company Name: ShenZhen GoodlyMed 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977239080056 [Primary]
GS1	16977239080053 [Package]; Contains: 06977239080056; Package: 1 [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241129

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2024-10-03
• Device Publish Date: 2024-09-25

Devices Manufactured by ShenZhen GoodlyMed Technology Co.,Ltd.

• 16977239080046 - CHANI: 2024-10-03
• 16977239080053 - /: 2024-10-03
• 16977239080053 - /: 2024-10-03
• 16977239080022 - ADKING: 2024-08-16
• 16977239080039 - N/A: 2024-08-16
• 06977239080018 - ADKING: 2024-08-09