AIRON CORPORATION

AIRON CORPORATION

Address:751 North Dr Unit 6,Melbourne,FL,32934,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilator, Continuous, Facility Use (CBK) (7) Ventilator, Emergency, Powered (Resuscitator) (BTL) (3)

Premarket Exempt

No

Clear

pNeuton - 00853678006009 Catalog Number : 20052

Device Description : pNeuton Ventilator, model A

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006016 Catalog Number : 20002

Device Description : pNeuton Ventilator, model S

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006023 Catalog Number : 20031

Device Description : pNeuton Ventilator, mini

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

MACS - 00853678006030 Catalog Number : 20201

Device Description : MACS CPAP System

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

MACS - 00853678006047 Catalog Number : 20301

Device Description : MACS epic CPAP System

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006054 Catalog Number : 58001

Device Description : Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

MACS - 00853678006078 Catalog Number : 58011

Device Description : Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet lo Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006092 Catalog Number : 58051

Device Description : Adult / pediatric patient circuit, disposable, single patient use, 8 feet long each.

Device Class :

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006115 Catalog Number : 58031

Device Description : Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 f Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each

Device Class :

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

pNeuton - 00853678006139 Catalog Number : 58035

Device Description : Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 f Child / pediatric patient circuit, disposable, single patient use, 15 mm ID, 6 foot long each.

Device Class : 2

Duns Number: 015222912

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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