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

Needle, Fistula (FIE) (6) Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO) (2) System, Dialysate Delivery, Single Patient (FKP) (2)

Premarket Exempt

Clear

NxStage PureFlow-B Solution - 00842289101258 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NxStage PureFlow-B Solution - 00842289101265 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NX2ME APP - 00842289101883 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKP

Prescription Use : Yes

Device Count : 1

NX2ME CLINICIAN PORTAL - 00842289101890 Catalog Number :

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FKP

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289101975 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" W/ STERIPICK INCLUDED with TWINP TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" W/ STERIPICK INCLUDED with TWINPACK BH-2005PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289101982 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" W/ STERIPICK TOTAL CASE QTY 250 TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289101999 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK INCLUDED WITH TWIN TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2006PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102002 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK TOTAL CASE QTY 250 TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102019 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK INCLUDED WITH TWIN TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2007PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102026 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK TOTAL CASE QTY 250 TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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