Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder A10-1308-01

GUDID 00817980020030

12 CH ECG Holter Ultra Recorder

VASOMEDICAL, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 00817980020030
• NIH Device Record Key: c4dd20eb-d044-4993-9e1b-cd5c69aa9d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder
• Version Model Number: Model 1308
• Catalog Number: A10-1308-01
• Company DUNS: 197210248
• Company Name: VASOMEDICAL, INC.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020030 [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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-11-29

Devices Manufactured by VASOMEDICAL, INC.

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• 00817980020016 - Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder: 2019-11-08 3 CH ECG Holter ULTRA Recorder
• 00817980020023 - Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder: 2019-11-08 12 CH ECG Holter Recorder
• 00817980020030 - Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder: 2019-11-0812 CH ECG Holter Ultra Recorder
• 00817980020030 - Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder: 2019-11-08 12 CH ECG Holter Ultra Recorder
• 00817980020047 - Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W: 2019-11-08 Ambulatory Blood Pressure Recorder
• 00817980020054 - Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W: 2019-11-08 Ambulatory Blood Pressure Recorder
• 00817980020061 - Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth: 2019-11-08 Ambulatory Blood Pressure Recorder w/Bluetooth
• 00817980020078 - Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor: 2019-11-08 3 CH ECG Holter/ABP COMBINED Recorder