G.LAB

GUDID 00853455007090

ACESO HEALTHCARE PRODUCTS, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00853455007090
• NIH Device Record Key: 8ca6c6d3-d9c5-46f3-98e0-cf347c50fcef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G.LAB
• Version Model Number: MD41W0
• Company DUNS: 058430522
• Company Name: ACESO HEALTHCARE PRODUCTS, INC.
• 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	00853455007090 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-21
• Device Publish Date: 2019-11-13

On-Brand Devices [G.LAB]

• 00853455007083: PR0200
• 00853455007076: PR0100
• 00853455007007: MD4180
• 00853455007151: MD2222
• 00853455007144: MD1180
• 00853455007113: MD2200
• 00853455007106: MD41W1
• 00853455007090: MD41W0