INTERNATIONAL BIOMEDICAL, LTD.

Address:8206 Cross Park Dr,AUSTIN,TX,78754,US

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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

Incubator, Neonatal Transport (FPL) (4) Apparatus, Nitric Oxide Delivery (MRN) (2) Unit, Neonatal Phototherapy (LBI) (1) Ventilator, Emergency, Powered (Resuscitator) (BTL) (1)

Premarket Exempt

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AeroNOx 2.0 Nitric Oxide Delivery Device - 00865648000337 Catalog Number : 731-9159

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : MRN

Prescription Use : Yes

Device Count : 1

Aviator Transport Incubator - 00868406000006 Catalog Number :

Device Description : Aviator Transport Incubator, with Optional PulseOx

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : FPL

Prescription Use : Yes

Device Count : 1

A750i Infant Incubator - 00868406000013 Catalog Number :

Device Description : A750i Infant Transport Incubator, with Optional PulseOx

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : FPL

Prescription Use : Yes

Device Count : 1

Voyager Infant Transport Incubator - 00868406000020 Catalog Number :

Device Description : Voyager Infant Transport Incubator, with Optional PulseOx

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : FPL

Prescription Use : Yes

Device Count : 1

185A+ Infant Incubator - 00868406000037 Catalog Number :

Device Description : 185A+ Infant Incubator

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : FPL

Prescription Use : Yes

Device Count : 1

LifeBorne Puffin Infant Resuscitator - 00868406000051 Catalog Number : 738-1099

Device Description : Puffin Infant Resuscitator

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

AeroNOx Nitric Oxide Delivery Device - 00868406000068 Catalog Number : 731-9148

Device Description : Nitric Oxide Delivery Device

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : MRN

Prescription Use : Yes

Device Count : 1

Airborne Phototherapy Light - 00868406000075 Catalog Number : 731-0209

Device Description : LED Phototherapy Light Bar

Device Class : 2

Duns Number: 073179368

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

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