BiPAP A30 1111144L

GUDID 00606959048744

BiPAP A30 Linde EOLUS 30, Italy

Respironics, Inc.

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator

• Primary Device ID: 00606959048744
• NIH Device Record Key: 029b2f29-948f-49d4-8f16-37c8d05e94e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiPAP A30
• Version Model Number: 00
• Catalog Number: 1111144L
• 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 Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959048744 [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