Electrodes, Holter, Button, 40 per Box, MP2E-40 A10-1200-03

GUDID 00817980020696

Electrodes, Holter, Button, 40 per Box, MP2E-40

VASOMEDICAL, INC.

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: 00817980020696
• NIH Device Record Key: a736c9e4-f9eb-48bb-8d69-9b47900a9fd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrodes, Holter, Button, 40 per Box, MP2E-40
• Version Model Number: Model 1200
• Catalog Number: A10-1200-03
• 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	00817980020696 [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

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