Lazle

GUDID 16927709414017

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16927709414017
• NIH Device Record Key: f3982022-d7de-4ada-b471-3fada1c60347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lazle
• Version Model Number: C04
• 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	06927709414010 [Primary]
GS1	16927709414017 [Package]; Contains: 06927709414010; Package: [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: 2020-10-20
• Device Publish Date: 2020-10-12

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

• 00810038637334 - Easy@Home Blood Pressure Monitor: 2024-12-11
• 00810038637440 - Easy@Home Blood Pressure Monitor: 2024-12-11
• 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