M DIALYSIS INC.

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

Device, Monitoring, Intracranial Pressure (GWM) (5) Medical Device Data System (OUG) (1)

Premarket Exempt

Clear

Control Samples US - 07332699000737 Catalog Number : 8010306

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

ICUpilot Software eng - 07332699000751 Catalog Number : 8001027

Device Class : 1

Duns Number: 824632087

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

70 Brain Microdialysis Catheter 60/10, 4/pkg - 07332699000911 Catalog Number : P000049

Device Description : Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane lengt Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

70 Brain Microdialysis Catheter 100/10, 4/pkg - 07332699000928 Catalog Number : P000050

Device Description : Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane leng Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

70 Microdialysis Bolt Catheter 130/10, 4/pkg - 07332699000973 Catalog Number : P000131

Device Description : Microdialysis catheter (20 kDa cut-off, 130 mm shaft length, 10 mm membrane leng Microdialysis catheter (20 kDa cut-off, 130 mm shaft length, 10 mm membrane length) for short term brain insertion using a bolt.

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

MD Pump Kit, Brain Tissue - 07332699001062 Catalog Number : 8003791

Device Class : 2

Duns Number: 824632087

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

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