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) (8) Oximeter, Tissue Saturation (MUD) (2) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (1)

Premarket Exempt

No Yes

Clear

Nonin - 00833166001082 Catalog Number :

Device Description : Universal Cable, Right Angle

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166001099 Catalog Number :

Device Description : Universal Cable, Right Angle

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166001112 Catalog Number :

Device Description : Wall Mount

Device Class :

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166001242 Catalog Number :

Device Description : Xpod LP with 7000A, 6000CA for use with GE ApexPro CH

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166001259 Catalog Number :

Device Description : Xpod LP with 600CA, 7000A for use with GE Apex Pro FH

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Nonin - 00833166001303 Catalog Number :

Device Description : Wrist Strap

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166001570 Catalog Number :

Device Description : T-Connector with Sample Line, 25-PK

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Nonin - 00833166002140 Catalog Number :

Device Description : 1 Meter Extension Cable

Device Class : 2

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA, MUD

Prescription Use : Yes

Device Count : 1

Nonin - 00833166003475 Catalog Number :

Device Description : Interface Cable

Device Class :

Duns Number: 174959692

Premarket Exempt : Yes

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nonin - 00833166003802 Catalog Number :

Device Description : 7600 PA Regional

Device Class : 2

Duns Number: 174959692

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

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