DYMEDIX DIAGNOSTICS, INC.

Address:5985 Rice Creek Pkwy Ste 200,Shoreview,MN,55126,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

Electrode, Cutaneous (GXY) (6) Monitor, Breathing Frequency (BZQ) (4)

Premarket Exempt

Clear

Perfect Fit - 00817377023057 Catalog Number :

Device Description : Dream Clear Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Precision Gold - 00817377023064 Catalog Number :

Device Description : Premium Disposable Adult EEG 9mm Cup Electrodes 2.5m (10 colored wires)

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Precision Gold - 00817377023071 Catalog Number :

Device Description : Premium Disposable Gold 9mm Cup EEG Electrode, 80" (2m), 10pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Precision Gold - 00817377023088 Catalog Number :

Device Description : Premium Disposable Gold 9mm Cup EEG Electrode, 40" (1m), 10pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Precision Gold - 00817377023095 Catalog Number :

Device Description : Premium Disposable Gold 9mm Cup EEG Electrode, 60" (1.5m), 10pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Electrodes - 00817377023101 Catalog Number :

Device Description : Chin Electrode Patch Infant

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Electrodes - 00817377023118 Catalog Number :

Device Description : XM Movement Sensor

Device Class :

Duns Number: 079976463

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377023125 Catalog Number :

Device Description : NOMAD Reusable Interface Kit

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377023132 Catalog Number :

Device Description : NOMAD Reusable Interface Kit

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377023149 Catalog Number :

Device Description : FastTrack Effort Interface Kit, NOX-T3

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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