Electrode, Holter, Button, 1 ea., MP2E-01 A10-1200-04

GUDID 00817980020702

Electrode, Holter, Button, 1 ea., MP2E-01

VASOMEDICAL, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00817980020702
• NIH Device Record Key: aae1debe-9c82-4eff-bae7-a819750b1583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrode, Holter, Button, 1 ea., MP2E-01
• Version Model Number: Model 1200
• Catalog Number: A10-1200-04
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

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 Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131190

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

Devices Manufactured by VASOMEDICAL, INC.

• 00817980020009 - Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder: 2019-11-08 3 CH ECG Holter Recorder
• 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: 2019-11-08 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