Vyntus ECG V-375610-13

GUDID 34250892906066

Vyaire Medical GmbH

Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 34250892906066
• NIH Device Record Key: 45d2bf9a-c3e3-4361-9ca1-31e984183627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vyntus ECG
• Version Model Number: V-375610-13
• Catalog Number: V-375610-13
• Company DUNS: 329769991
• Company Name: Vyaire Medical GmbH
• 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: true
• 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: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	34250892906066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150810

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2021-07-26
• Device Publish Date: 2021-07-16

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