Micro Medical 36-ML3500 MK8-REGION 2&3

GUDID 54250892901393

MicroLab

Vyaire Medical GmbH

Diagnostic spirometer

• Primary Device ID: 54250892901393
• NIH Device Record Key: 269438fd-2e23-47fd-9694-a9f1f8632073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro Medical
• Version Model Number: 36-ML3500 MK8-REGION 2&3
• Catalog Number: 36-ML3500 MK8-REGION 2&3
• 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
• 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
• 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
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu@vyaire.com

Operating and Storage Conditions

• 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
• 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
• 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
• 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	54250892901393 [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: 3
• Public Version Date: 2019-03-18
• Device Publish Date: 2018-03-31

On-Brand Devices [Micro Medical]

• 54250892904202: MicroLoop
• 54250892904196: MicroLoop
• 54250892902994: MicroLoop
• 54250892902987: MicroDiary
• 54250892901591: SpiroUSB
• 54250892901584: SmokeCheck
• 54250892901577: PulmoLife
• 54250892901560: PulmoLife
• 54250892901553: PulmoLife
• 54250892901546: MicroRPM
• 54250892901515: MicroLoop
• 54250892901508: MicroLoop
• 54250892901461: MicroLoop
• 54250892901423: MicroLab
• 54250892901393: MicroLab
• 54250892901386: MicroLab
• 54250892901362: MicroCO
• 54250892901355: Micro I
• 54250892901157: MicroDiary
• 14250892902040: BACTERIAL FILTER
• 14250892901951: MICRO TURBINE COMPLETE
• 14250892901944: Nose clip pad
• 14250892901937: Nose Clip
• 14250892901920: Microgard Filter adaptor
• 14250892901913: Microgard Filter adaptor
• 14250892901906: Nasal Probe Adaptor
• 14250892901890: Mouthpiece adaptor
• 14250892901883: INSPIRATORY PRESSURE VALVE
• 14250892901876: EXPIRATORY PRESSURE VALVE
• 14250892901869: MOUTHPIECE ADAPTOR
• 14250892901852: ADULT Mouthpiece
• 14250892901845: PAEDIATRIC ADAPTOR
• 14250892901838: MOUTHPIECE ADAPTOR
• 14250892901821: Turbine Complete
• 14250892901814: Turbine Complete
• 14250892901807: Turbine Complete
• 14250892901777: Bacterial Filter and Adapter 1 Pack, Consits of 50 EA 36-MEC1107 Bacterial Filter
• 14250892901760: Rubber Flanged Mouthpiece Qty: 1 pack Consits of 10 36-MTH6400 Rubber Flanged Mouthpiece
• 14250892901753: Universal Mouthpiece
• 14250892901746: Adult Mouthpieces 1 Way
• 14250892901739: Rubber Flanged Mouthpiece
• 14250892901722: Paediatric Mouthpiece
• 14250892901715: BACTERIAL FILTER Qty: 1 Pack of 50
• 14250892901708: ACC NASAL PROBE SET, Consits of 1 EA 36-NPROBE01 Extra Small Nasal Probes 1 EA 36
• 14250892901678: Large Nasal Probes
• 14250892901661: Medium Nasal Probes
• 14250892901654: Small Nasal Probes
• 14250892901647: Extra Small Nasal Probes
• 14250892903849: Microgard Filter Adapter