Alcedo

GUDID 10856471007096

Upper Arm Blood Pressure Monitor

NATURE MAJOR INC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10856471007096
• NIH Device Record Key: 3e4c1897-bcbe-4e2b-b488-5ea65013f222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcedo
• Version Model Number: B21
• Company DUNS: 114908257
• Company Name: NATURE MAJOR 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: true
• 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	00856471007099 [Primary]
GS1	10856471007096 [Package]; Contains: 00856471007099; Package: Master Carton [20 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-09

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