BB-613W Wrist-Monitor BB90000100000

GUDID 07290020154101

BIOBEAT TECHNOLOGIES LTD

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 07290020154101
• NIH Device Record Key: 2f6f589a-58bb-4afb-aa23-6fdac5c1b4e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BB-613W Wrist-Monitor
• Version Model Number: 1.1.0
• Catalog Number: BB90000100000
• Company DUNS: 532193771
• Company Name: BIOBEAT TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290020154101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222010

FDA Product Code

• DQA: Oximeter

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by BIOBEAT TECHNOLOGIES LTD

• 07290020154422 - BB-613 BPM KIT: 2025-03-18
• 07290020154101 - BB-613W Wrist-Monitor: 2025-03-13
• 07290020154101 - BB-613W Wrist-Monitor: 2025-03-13
• 07290020154309 - BB-613 H@H kit: 2025-03-13
• 17290020154009 - BB-613P Chest-Monitor 40-Unit Multipack: 2025-03-13
• 07290020154408 - BB-613 BPM 16-Unit Multipack: 2025-03-13