Vyntus V-707708

GUDID 14250892901203

DVT Adapter w. salvia trap

Vyaire Medical GmbH

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: 14250892901203
• NIH Device Record Key: 68236d69-fbc8-4693-84e7-c7ff6904fbb4
• Commercial Distribution Discontinuation: 2019-06-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vyntus
• Version Model Number: V-707708
• Catalog Number: V-707708
• 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: true
• 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: false
• 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
• 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
• 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

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage 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	14250892901203 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-04
• Device Publish Date: 2018-07-02

On-Brand Devices [Vyntus]

• 04250892902661: Vyntus ONE
• 04250892902609: Vyntus ONE
• 04250892902593: Vyntus ONE
• 04250892902586: Vyntus ONE
• 04250892901084: Vyntus ONE
• 34250892902334: Cart Vyntus 3.0 115V
• 34250892902327: Cart Vyntus 3.0 230V
• 34250892901276: Rebreathing bag 20 L
• 14250892901487: DVT complete
• 14250892901449: LED Holder
• 14250892901432: TwinTube collection tube
• 14250892901326: Plug-in
• 14250892901319: Canopy tube
• 14250892901203: DVT Adapter w. salvia trap