1 BY ONE

GUDID 00858069007221

1BYONEPRODUCTS INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00858069007221
• NIH Device Record Key: 1b0c2daa-790a-4915-8a5e-d312890e8193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1 BY ONE
• Version Model Number: 703NA-0005
• Company DUNS: 845019202
• Company Name: 1BYONEPRODUCTS 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: false
• 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	00858069007207 [Primary]
GS1	00858069007221 [Package]; Contains: 00858069007207; Package: inner case [1 Units]; Discontinued: 2020-06-29; Not in Commercial Distribution
GS1	10858069007228 [Package]; Package: carton [18 Units]; Discontinued: 2020-06-29; Not in Commercial Distribution

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: 2020-07-07
• Device Publish Date: 2020-06-29