M DIALYSIS INC.

Address:73 PRINCETON ST.,N Chelmsford,MA,01863,US

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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

Device, Monitoring, Intracranial Pressure (GWM) (5) General Purpose Reagent (PPM) (4) Box, Battery, Pocket (FCP) (1)

Premarket Exempt

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106 Microdialysis Pump - 07332699000034 Catalog Number : P000003

Device Description : Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microd Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microdialysis sampling. The pump is prepared with the Battery (07332699000058) and the 106 Syringe (07332699000072) filled with the Perfusion Fluid (07332699000263) and finally connected to the Microdialysis catheter.The 106 Microdialysis Pump is easy to operate. An initial flush is performed automatically. Flushes can be initiated manually if necessary.

Device Class :

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

Battery 2x3V, 106 MD Pump - 07332699000058 Catalog Number : 8001788

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : FCP

Prescription Use : No

Device Count : 1

106 Syringe - 07332699000072 Catalog Number : 8010191

Device Class :

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 20

Microvial rack 12/pkg - 07332699000249 Catalog Number : P000028

Device Class :

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 12

Microvials 250/pkg - 07332699000256 Catalog Number : P000001

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

Perfusion fluid CNS - 07332699000263 Catalog Number : P000151

Device Class :

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 10

Glutamate reagent - 07332699000287 Catalog Number : P000064

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : PPM

Prescription Use : No

Device Count : 1

Glycerol reagent - 07332699000294 Catalog Number : P000025

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : PPM

Prescription Use : No

Device Count : 1

Reagent Kit - 07332699000300 Catalog Number : P000011

Device Description : Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : PPM

Prescription Use : No

Device Count : 1

Lactate reagent - 07332699000317 Catalog Number : P000024

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : PPM

Prescription Use : No

Device Count : 1

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