RENPHO

GUDID 10860002249626

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10860002249626
• NIH Device Record Key: 08be8d42-e4a5-409c-8008-a2e2d4439059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO
• Version Model Number: B02
• Company DUNS: 421350239
• Company Name: Shenzhen Jamr 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: 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	00860002249629 [Primary]
GS1	10860002249626 [Package]; Contains: 00860002249629; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172171

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: 2019-12-20
• Device Publish Date: 2019-12-12

Devices Manufactured by Shenzhen Jamr Medical Technology Co., Ltd.

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• 16927709466030 - Blood Pressure Monitor: 2022-05-30
• 16927709415168 - cigii: 2022-03-01 Blood Pressure Monitor
• 16927709421039 - CIEKAA: 2022-02-28 Blood Pressure Monitor
• 16927709402465 - LOVIA: 2022-01-18 Blood Pressure Monitor