WITHINGS

GUDID 04719873310029

BP-801 is the device for the measurement of blood pressure & pulse rate of patient.

YA HORNG ELECTRONIC CO., LTD.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04719873310029
• NIH Device Record Key: d78332f9-72b8-4d94-a0d8-81c182973e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WITHINGS
• Version Model Number: BP-801
• Company DUNS: 656103819
• Company Name: YA HORNG ELECTRONIC 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873310029 [Primary]
GS1	14719873310026 [Package]; Package: [10 Units]; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-07

On-Brand Devices [WITHINGS]

• 14719873310033: BP-801 is the device for the measurement of blood pressure & pulse rate of patient.
• 04719873310029: BP-801 is the device for the measurement of blood pressure & pulse rate of patient.
• 04719873310012: SCT01 is the device for the measurement of body temperature.
• 04719873310005: BP-801 is the device for the measurement of blood pressure & pulse rate of patient