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) (5) Oximeter, Tissue Saturation (MUD) (5) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (1)

Premarket Exempt

No Yes

Clear

Nonin - 00849686074727 Catalog Number :

Device Description : PalmSAT Handheld Pulse Oximeter

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074741 Catalog Number :

Device Description : Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANO Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074758 Catalog Number :

Device Description : Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANO Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074765 Catalog Number :

Device Description : Adult Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with Adult Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074772 Catalog Number :

Device Description : Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANO Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

Device Class :

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

nonin - 00849686074789 Catalog Number :

Device Description : Reflectance Pulse Oximeter Sensor

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686074833 Catalog Number :

Device Description : NoninConnect Elite™ Model 3240 Bluetooth® Smart Pulse Oximeter

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686075274 Catalog Number :

Device Description : Battery Pack

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : CCK, DQA

Prescription Use : No

Device Count : 1

Nonin - 00849686075410 Catalog Number :

Device Description : RTC Cable

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00849686075571 Catalog Number :

Device Description : Intermediate Cable

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

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