Vitalcontrol Type: SBM46/1

GUDID 00852547004962

Upper Arm Blood Pressure Monitor

BEURER NORTH AMERICA, L.P.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00852547004962
• NIH Device Record Key: 5113ca07-e060-47e6-bfd7-ecb7fff8126d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitalcontrol
• Version Model Number: SBM46
• Catalog Number: Type: SBM46/1
• Company DUNS: 078497467
• Company Name: BEURER NORTH AMERICA, L.P.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-536-0366
• Email: info@beurer.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852547004962 [Primary]
GS1	10852547004969 [Package]; Package: Case [4 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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-01-09

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