C0MFIER /

GUDID 16927709415137

Blood Pressure Monitor

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16927709415137
• NIH Device Record Key: 100f0497-4f07-4347-a7b5-8a204dd2f745
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C0MFIER
• Version Model Number: B15
• Catalog Number: /
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06927709415130 [Primary]
GS1	16927709415137 [Package]; Contains: 06927709415130; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200437

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: 2021-09-30
• Device Publish Date: 2021-09-22

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

• 06927709400976 - Ovutek: 2024-08-05
• 16927709401857 - PEAKME: 2024-08-05
• 16927709401864 - PEAKME: 2024-08-05
• 06927709401942 - N/A: 2024-08-05
• 06927709401966 - Ovutek: 2024-08-05
• 06927709486055 - DOUHAO: 2023-05-22
• 06927709423111 - Blood Pressure Monitor: 2022-12-14
• 16927709423101 - Blood Pressure Monitor: 2022-08-24