NXSTAGE MEDICAL, INC.

Address:350 Merrimack St,LAWRENCE,MA,01843,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

Subsystem, Proportioning (FKR) (6) Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (FJK) (2) Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (1)

Premarket Exempt

Clear

Dialysate Sack (SAK) with Concentrate - M535SAK4050 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Dialysate Sack (SAK) with Concentrate - M535SAK405A0 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Dialysate Sack (SAK) with Concentrate - M535SAK4060 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Dialysate Sack (SAK) with Concentrate - M535SAK406A0 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Dialysate Sack (SAK) with Concentrate - M535SAK4070 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Dialysate Sack (SAK) with Concentrate - M535SAK407A0 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKR

Prescription Use : Yes

Device Count : 1

Streamline Airless System Set with Locksite Needleless Access Sites - M535SL2000M2095W0 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Streamline Airless System Set with Locksite Needleless Access Sites - M535SL2050M20550 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

NXSTAGE SPEEDSWAP EXPRESS KIT - M535SSK5350 Catalog Number :

Device Class :

Duns Number: 088013219

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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