N/A

GUDID 16977239080039

ShenZhen GoodlyMed Technology Co.,Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16977239080039
• NIH Device Record Key: a32de5b9-6875-4706-a7b2-41372dca0aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: A01-BL
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977239080032 [Primary]
GS1	16977239080039 [Package]; Contains: 06977239080032; Package: Carton [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: 2024-08-16
• Device Publish Date: 2024-08-08

On-Brand Devices [N/A]

• 16977239080039: A01-BL
• 16977239080114: A01-BS