aironusa.com
inspiration-healthcare.comPNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
AIRON CORPORATION
AIRON CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003697063 | 3003697063 | AIRON CORPORATION | 1 | Y | 2026-01-01 | 751 North Dr Unit 6 Melbourne FL US 32934 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00853678006054 | pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each | 321-821-9433 | info@aironusa.com |
| 00853678006078 | MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each. | 3218219433 | info@aironusa.com |
| 00853678006139 | pNeuton - Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each. | 321-821-9433 | info@aironusa.com |
| 00853678006634 | pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long with expiratory filter each. | 321-821-9433 | info@aironusa.com |
| 00853678006658 | MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long, with large mask, head strap and expiratory filter each | 3218219433 | info@aironusa.com |
| 00853678006696 | pNeuton - Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each. | 321-821-9433 | info@aironusa.com |
| 00853678006726 | pNeuton Model A Start-up Kit with 8ft Patient Circuit - A | 888-448-1238 | airontechnicalsupport@inspiration-healthcare.com |
| 00853678006733 | pNeuton Model A with 6ft Patient Circuit - 58051 - 6 ft. Patient Circuit, | 888-448-1238 | airontechnicalsupport@inspiration-healthcare.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20846 | 1180567074 | K925217 | MERIDIAN MEDICAL SYSTEMS BREATHING FILTER | CAH | 1993-01-26 |
| 20846 | 1127750471 | K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY | CBK | 2012-10-11 |
| 20846 | 1962605827 | K080692 | MACS CPAP SYSTEM | BTL | 2008-06-20 |
| 20846 | 1386707639 | K043085 | MODIFICATION TO: PNEUTON VENTILATOR | CBK | 2004-12-20 |
| 20846 | 1160056421 | K024344 | PNEUTON VENTILATOR | CBK | 2003-06-03 |
Product Codes Associated With Registrations#
PMN#
MACS CPAP SYSTEM
AIRON CORPORATION
MODIFICATION TO: PNEUTON VENTILATOR
AIRON CORPORATION
PNEUTON VENTILATOR
AIRON CORPORATION
GUDID#
pNeuton Model A with 6ft Patient Circuit - 58051 - 6 ft. Patient Circuit,
2025-12-19
pNeuton Model A Start-up Kit with 8ft Patient Circuit - A
2025-12-18
pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each
2016-09-24
MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.
2016-09-24
pNeuton - Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each.
2016-09-24
pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long with expiratory filter each.
2016-09-24
MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long, with large mask, head strap and expiratory filter each
2016-09-24
pNeuton - Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each.
2019-06-17
pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 8 feet long each.
2016-09-24
pNeuton - Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each
2016-09-24
miniFlow - miniFlow Nasal Prongs, size wide large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Prongs, size x large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Prongs, size large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Prongs, size medium, single patient use each
2016-09-24
miniFlow - miniFlow Nasal Prongs, size small, single patient use each
2016-09-24
miniFlow - miniFlow Nasal Prongs, size micro, single patient use each.
2016-09-24
miniFlow - miniFlow nCPAP Patient Interface
2016-09-24
miniFlow - miniFlow Nasal Prongs, size medium wide, single patient use each.
2016-09-24
pNeuton - Bacterial/Viral Filter, main line or expiratory
2017-01-10
pNeuton - Bacterial/Viral Filter, main line or expiratory
2017-01-10
pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each
2016-09-24
MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.
2016-09-24
pNeuton - Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each.
2016-09-24
pNeuton - Adult / pediatric patient circuit, disposable, single patient use, 6 feet long with expiratory filter each.
2016-09-24
MACS - Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long, with large mask, head strap and expiratory filter each
2016-09-24
pNeuton - pNeuton Ventilator, mini neo
2019-10-11
miniFlow - miniFlow Nasal Prongs, size x large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Mask, size x large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Mask, size large, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Mask, size medium, single patient use each.
2016-09-24
miniFlow - miniFlow Nasal Mask, size small, single patient use each.
2016-09-24
miniFlow - Bonnet, size x small, single patient use each.
2016-09-24
miniFlow - Bonnet, size small, single patient use each.
2016-09-24
miniFlow - Bonnet, size medium, single patient use each.
2016-09-24
miniFlow - Bonnet, size large, single patient use each.
2016-09-24
miniFlow - Bonnet, size x large, single patient use each.
2016-09-24
miniFlow - Bonnet, size xx large, single patient use each.
2016-09-24
miniFlow - Bonnet, size xxx large, single patient use each.
2016-09-24
miniFlow - Attachment Strip for bonnets, size 13 cm, single patient use each.
2016-09-24
miniFlow - Attachment Strip for bonnets, size 15 cm, single patient use each.
2016-09-24