Micro Medical 36-ASS1221

GUDID 14250892901876

EXPIRATORY PRESSURE VALVE

Vyaire Medical GmbH

Airway pressure monitor, powered

• Primary Device ID: 14250892901876
• NIH Device Record Key: 47ee2e03-87be-4e85-8742-31267c337a7b
• Commercial Distribution Discontinuation: 2019-05-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Micro Medical
• Version Model Number: 36-ASS1221
• Catalog Number: 36-ASS1221
• Company DUNS: 329769991
• Company Name: Vyaire Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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@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
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling 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	14250892901876 [Primary]

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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: 2019-05-28
• Device Publish Date: 2018-05-11

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• 54250892901386: MicroLab
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• 54250892901157: MicroDiary
• 14250892902040: BACTERIAL FILTER
• 14250892901951: MICRO TURBINE COMPLETE
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• 14250892901937: Nose Clip
• 14250892901920: Microgard Filter adaptor
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• 14250892901906: Nasal Probe Adaptor
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• 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