INOVO, INC.

INOVO, INC.

Address:401 Leonard Blvd N,Lehigh Acres,FL,33971,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

Conserver, Oxygen (NFB) (7) Generator, Oxygen, Portable (CAW) (3)

Premarket Exempt

No Yes

Clear

Pure Concentrator - 00814470020006 Catalog Number : NA

Device Description : CONCENTRATOR, DRIVE, OCI

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Pure Concentrator - 00814470020013 Catalog Number :

Device Description : CONCENTRATOR, DRIVE, NON-OCI

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

PUREFILL - 00814470020020 Catalog Number :

Device Description : PUREFILL UNIT

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

BONSAI - 00814470020037 Catalog Number :

Device Description : Bonsai Velocity Conserver

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

Evolution™ - 00814470020044 Catalog Number :

Device Description : Evolution™ Electronic Oxygen Conserver

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR - 00814470020051 Catalog Number :

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

SMARTDOSE - 00814470020075 Catalog Number :

Device Description : SmartDose® Mini Auto-Adjusting Oxygen Conserver

Device Class :

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

CYPRESS - 00814470020082 Catalog Number :

Device Description : Pneumatic Oxygen Conserver

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

Evolution™ - 00814470020105 Catalog Number :

Device Description : Evolution™ Electronic Oxygen Conserver

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

OXYMIZER - 00814470020112 Catalog Number :

Device Description : Oxymizer® Disposable Oxygen Conserver

Device Class : 2

Duns Number: 015954530

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

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