Beurer 162.934

GUDID 10850003500611

XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1)

BEURER NORTH AMERICA, L.P.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10850003500611
• NIH Device Record Key: a61fa885-184e-485d-80f0-cc309a6c78a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beurer
• Version Model Number: BM35 XL Cuff (replacement)
• Catalog Number: 162.934
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003500614 [Primary]
GS1	10850003500611 [Package]; Contains: 00850003500614; Package: Case Pack [50 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-21
• Device Publish Date: 2020-01-13

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• 20852547004645: Wrist Blood Pressure Monitor
• 00852547004603: BM47 Universal Cuff (replacement)
• 10852547004556: Glass Body Analysis Scale
• 10852547004457: BM47 XL Cuff (replacement)
• 10852547004396: Body Fat Scale
• 20852547004348: TENS Device
• 20852547004287: Upper Arm Blood Pressure Monitor * with cuff size 8.7 - 16.5 in (22 - 42 cm)
• 10852547004273: BM47 Blood Pressure Monitor with Universal Cuff (22 - 42 cm)
• 10852547004266: Body Fat Scale
• 10852547004211: Fingertip Pulse Oximeter (for wellness)
• 10852547004129: Non-contact IR Clinical Thermometer
• 10852547004112: Body Fat Scale
• 10852547004105: Infrared Lamp
• 20852547004058: Portable Nebulizer
• 00852547004009: IR EAR THERMOMETER DISPOSABLE PROBE COVERS
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• 10850003500215: Fascia Massager (Light Wood)
• 20853879007144: EMS Abdominal Muscle Belt
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• 10852547004181: Glass Body Analysis Scale
• 20850003500526: Digital TENS Device
• 20850003500502: Wrist Blood Pressure Monitor
• 20850003500434: Basal Thermometer with Ovy App
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• 00850003500669: Massager
• 10850003500642: Non-contact IR Clinical Thermometer
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