maguja

GUDID 06951727601879

Shenzhen Changkun Technology Co., Ltd.

Blood pressure alarm

• Primary Device ID: 06951727601879
• NIH Device Record Key: c869785c-2d78-466d-bbca-eea65256cd1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: maguja
• Version Model Number: CK-W118
• Company DUNS: 554502671
• Company Name: Shenzhen Changkun 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: true
• 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	06951727601879 [Primary]
GS1	16951727601883 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193386

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: 2023-04-24
• Device Publish Date: 2023-04-14

Devices Manufactured by Shenzhen Changkun Technology Co., Ltd.

• 06951727601879 - maguja: 2023-04-24
• 06951727601879 - maguja: 2023-04-24
• 06951727601459 - Handy Solutions: 2022-10-06