NIDEK MEDICAL PRODUCTS, INC.

Address:3949 VALLEY EAST INDUSTRIAL DR,Birmingham,AL,35217,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

Generator, Oxygen, Portable (CAW) (10)

Premarket Exempt

Clear

MARK 5 NUVO LITE - 00038214000028 Catalog Number : 920

Device Description : 230V/ 50HZ STD OXYGEN CONCENTRATOR - EURO PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE - 00038214000035 Catalog Number : 925

Device Description : 230V/50HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE - 00038214000066 Catalog Number : 925-IS

Device Description : 230V/50HZ OCSI OXYGEN CONCENTRATOR - ISRAELI PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE3 - 00038214000073 Catalog Number : 935UK

Device Description : 230V/50HZ OCSI OXYGEN CONCENTRATOR - UK PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE3 - 00038214000080 Catalog Number : 935

Device Description : 230V/50HZ OCSI OXYGEN CONCENTRATOR

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE - 00038214000097 Catalog Number : 920NI

Device Description : 230V/50HZ STD OXYGEN CONCENTRATOR -- INDIA PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO 8 - 00038214000226 Catalog Number : 980

Device Description : 230V STD 8LPM OXYGEN CONCENTRATOR

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO 8 - 00038214000233 Catalog Number : 985

Device Description : 230V OCSI 8LPM OXYGEN CONCENTRATOR

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE - 00038214000370 Catalog Number : 920/60

Device Description : 230V/60HZ STD OXYGEN CONCENTRATOR - EURO PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

MARK 5 NUVO LITE - 00038214000431 Catalog Number : 925/60

Device Description : 230V/60HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG

Device Class : 2

Duns Number: 161382940

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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