NULINE SENSORS, LLC

Address:210 Specialty Pt,Sanford,FL,32771,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, Electrocardiograph (DRX) (2) Cable, Electrode (IKD) (1)

Premarket Exempt

Yes

Clear

EKG Patch™ (Medium) - 00850018485005 Catalog Number : MGMED

Device Description : Electrode, Electrocardiograph

Device Class : 2

Duns Number: 079231054

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : No

Device Count : 1

EKG Patch™ (Large) - 00850018485012 Catalog Number : MGLRG

Device Description : Electrode, Electrocardiograph

Device Class : 2

Duns Number: 079231054

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : No

Device Count : 1

EKG Patch™ (Cable) - 00850018485029 Catalog Number : MGCBLSP

Device Description : Cable, Electrode

Device Class : 2

Duns Number: 079231054

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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