MicroMedical 36-SWR1134

GUDID 04250892901633

Spirometry PC Software

Vyaire Medical GmbH

Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult

• Primary Device ID: 04250892901633
• NIH Device Record Key: 4ade8122-699c-45a9-8b55-a081ca4aa475
• Commercial Distribution Discontinuation: 2019-05-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MicroMedical
• Version Model Number: 2.5
• Catalog Number: 36-SWR1134
• 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: false
• Manufacturing Date: true
• 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@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892901633 [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