G.LAB

GUDID 04895045403611

Grandway Technology (Shenzhen) Limited

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04895045403611
• NIH Device Record Key: 7d51ad59-1fc8-4023-b355-549406b3226d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G.LAB
• Version Model Number: MD2010
• Company DUNS: 420764247
• Company Name: Grandway Technology (Shenzhen) Limited
• 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	04895045403611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140583

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-02-13

On-Brand Devices [G.LAB]

• 04895045403666: MD3150
• 04895045403659: MD2580
• 04895045403642: MD2231
• 04895045403635: MD2222
• 04895045403628: MD2200
• 04895045403611: MD2010
• 04895045403604: MD1520
• 04895045403598: MD1180
• 08534550072122: MD5470
• 04895045404021: MD5940