MicroMedical 36-SPC0105-STK

GUDID 34250892901610

Spirometry PC Software Licence

Vyaire Medical GmbH

Pulmonary function analysis system, adult

• Primary Device ID: 34250892901610
• NIH Device Record Key: a2364a88-c9fe-427b-8a44-adb7d7582666
• Commercial Distribution Discontinuation: 2019-05-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MicroMedical
• Version Model Number: 2.5
• Catalog Number: 36-SPC0105-STK
• 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@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	34250892901610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141936

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2019-05-28
• Device Publish Date: 2018-03-31

On-Brand Devices [MicroMedical]

• 04250892901633: Spirometry PC Software
• 34250892902020: Adult Mouthpiece
• 34250892902013: Paediatric Mouthpiece
• 34250892902006: Adult Mouthpiece
• 34250892901993: Adult One Way Mouthpiece
• 34250892901986: Adult One Way Mouthpiece
• 34250892901627: Spirometry PC Software Update
• 34250892901610: Spirometry PC Software Licence
• 34250892901603: Spirometry PC Software
• 34250892901535: MicroPeak
• 34250892901528: MicroPeak