pNeuton Model A with 6ft Patient Circuit 20059

GUDID 00853678006733

58051 - 6 ft. Patient Circuit,

AIRON CORPORATION

Portable pneumatic ventilator

• Primary Device ID: 00853678006733
• NIH Device Record Key: b5b8b8cf-f9e6-4d02-8d84-8adf624540bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pNeuton Model A with 6ft Patient Circuit
• Version Model Number: A
• Catalog Number: 20059
• Company DUNS: 015222912
• Company Name: AIRON CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com
• Phone: 888-448-1238
• Email: airontechnicalsupport@inspiration-healthcare.com

Device Dimensions

• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch
• Weight: 6.5 Pound
• Depth: 7.3 Inch
• Height: 5 Inch
• Width: 10 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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	00853678006733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043085

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2025-12-29
• Device Publish Date: 2025-12-19

Devices Manufactured by AIRON CORPORATION

• 00853678006733 - pNeuton Model A with 6ft Patient Circuit: 2025-12-2958051 - 6 ft. Patient Circuit,
• 00853678006733 - pNeuton Model A with 6ft Patient Circuit: 2025-12-29 58051 - 6 ft. Patient Circuit,
• 00853678006689 - pNeuton: 2020-02-06 Bacterial/Viral Filter, main line or expiratory
• 00853678006696 - pNeuton: 2019-11-27 Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each.
• 00853678006061 - pNeuton: 2019-11-27 Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each
• 00853678006085 - MACS: 2019-11-27 Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.
• 00853678006092 - pNeuton: 2019-11-27 Adult / pediatric patient circuit, disposable, single patient use, 8 feet long each.
• 00853678006115 - pNeuton: 2019-11-27 Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each
• 00853678006146 - pNeuton: 2019-11-27 Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each.