BiPAP A30 1111144V

GUDID 00606959048768

BiPAP A30 Vitalaire Vitalvent 30, Italy

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959048768
• NIH Device Record Key: 7b342835-fa1f-4c28-a2e3-8a9165bba0b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiPAP A30
• Version Model Number: 00
• Catalog Number: 1111144V
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959048768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113053

FDA Product Code

• MNS: Ventilator, continuous, non-life-supporting

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

On-Brand Devices [BiPAP A30]

• 00606959021532: BiPAP A30 Australia
• 00606959042827: BiPAP A30 Silver Series FGD SA
• 00606959042728: BiPAP A30-S Silver Series, FGD SA
• 00606959042711: BiPAP A30, FGD SA, France
• 00606959042704: BiPAP A30, FGD SA, China
• 00606959042698: BiPAP A30 Ventilatory Support System, Brazil
• 00606959042681: BiPAP A30 FGD SA, International, Private Label
• 00606959042667: BiPAP A30, FGD SA
• 00606959039452: BiPAP A30 China
• 00606959039445: BiPAP A30 Brazil
• 00606959039421: BiPAP A30 Ventilatory Support System, International version (Medicair Respicomfort unit)
• 00606959039414: BiPAP A30 Vitalaire Vitalvent 30
• 00606959039407: BiPAP A30 Linde EOLUS 30
• 00606959039384: BiPAP A30 Silver Series
• 00606959039360: BiPAP A30-S Silver Series
• 00606959039353: BiPAP A30 Ventilatory Support System, France
• 00606959039346: BiPAP A30 Canada, Heated Tube Core Package
• 00606959039339: BiPAP A30, Canada
• 00606959039322: BiPAP A30 Australia Core Package
• 00606959039315: BiPAP A30 Ventilatory Support System, International (Private Label unit)
• 00606959039308: BiPAP A30, International
• 00606959048768: BiPAP A30 Vitalaire Vitalvent 30, Italy
• 00606959048751: BiPAP A30 Medicair Respicomfort, Italy
• 00606959048744: BiPAP A30 Linde EOLUS 30, Italy