pNeuton 58201

GUDID 00853678006696

Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each.

AIRON CORPORATION

Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use

• Primary Device ID: 00853678006696
• NIH Device Record Key: 93c292cb-6b1a-48eb-a16c-bf32e1734f2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pNeuton
• Version Model Number: 58201
• Catalog Number: 58201
• Company DUNS: 015222912
• Company Name: AIRON CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com
• Phone: 321-821-9433
• Email: info@aironusa.com

Device Dimensions

• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch
• Weight: 0.437 Pound
• Length: 96 Inch
• Width: 0.6 Inch
• Height: 0.6 Inch

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -52 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853678006696 [Primary]
GS1	00853678006702 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121379

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-06-17

On-Brand Devices [pNeuton]

• 00853678006689: Bacterial/Viral Filter, main line or expiratory
• 00853678006641: Adult / pediatric patient circuit, disposable, single patient use, 6 feet long with expiratory f
• 00853678006146: Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each.
• 00853678006115: Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each
• 00853678006092: Adult / pediatric patient circuit, disposable, single patient use, 8 feet long each.
• 00853678006061: Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each
• 00853678006023: pNeuton Ventilator, mini
• 00853678006016: pNeuton Ventilator, model S
• 00853678006009: pNeuton Ventilator, model A
• 00853678006696: Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each.
• 00853678006719: pNeuton Ventilator, mini neo