Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG A10-0031

GUDID 00817980020139

CB Series Analysis & Reporting Software - 3 & 12 CH ECG

VASOMEDICAL, INC.

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: 00817980020139
• NIH Device Record Key: d1a4409f-6e70-4533-8099-f9a8d3b5dd0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG
• Version Model Number: CB Series S/W
• Catalog Number: A10-0031
• Company DUNS: 197210248
• Company Name: VASOMEDICAL, INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com
• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111180

FDA Product Code

• DSH: RECORDER, MAGNETIC TAPE, MEDICAL

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: 2018-07-06
• Device Publish Date: 2016-11-29

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• 00817980020078 - Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor: 2019-11-08 3 CH ECG Holter/ABP COMBINED Recorder