BEMER Therapy Systems 420100

GUDID 07640161461017

Bemer Int. AG

Hand-held deep-tissue electromagnetic stimulator

• Primary Device ID: 07640161461017
• NIH Device Record Key: cb9f52c6-a602-458a-875e-4802929561a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEMER Therapy Systems
• Version Model Number: B.BOX Classic
• Catalog Number: 420100
• Company DUNS: 448002860
• Company Name: Bemer Int. AG
• 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	07640161461017 [Package]; Contains: 07640161462014; Package: [1 Units]; In Commercial Distribution
GS1	07640161461031 [Package]; Contains: 07640161462014; Package: [4 Units]; In Commercial Distribution
GS1	07640161462014 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2018-03-29
• Device Publish Date: 2017-05-03

On-Brand Devices [BEMER Therapy Systems]

• 07640161461048: B.BOX Professional
• 07640161461017: B.BOX Classic
• 07640161461055: Professional