NONIN MEDICAL, INC.

Address:13700 1ST AVE, NORTH,Plymouth,MN,55441,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

Oximeter (DQA) (9) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (1)

Premarket Exempt

No Yes

Clear

Nonin - 00849686074482 Catalog Number :

Device Description : Carbon Dioxide Sensor

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074529 Catalog Number :

Device Description : Onyx Finger Pulse Oximeter

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074567 Catalog Number :

Device Description : Flex Sensor and FlexiWrap®

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074574 Catalog Number :

Device Description : Flex Sensor and FlexiWrap

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074581 Catalog Number :

Device Description : Reusable Adult Flex Pulse Oximeter Sensor, 20 CM and FlexiWrap® Single Use Sensor Wrap,

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074598 Catalog Number :

Device Description : Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Us Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074604 Catalog Number :

Device Description : Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Us Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap, 3 Meter

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074666 Catalog Number :

Device Description : Interface Cable

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : No

Device Count : 1

Nonin - 00849686074703 Catalog Number :

Device Description : Ear Clip Pulse Oximeter Sensor

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074710 Catalog Number :

Device Description : 2500A Handheld Pulse Oximeter with Alarms

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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