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) (10)

Premarket Exempt

Clear

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102231 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWI TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102248 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUSTotal Case Qty 250 TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUSTotal Case Qty 250 (120 Twin pouches + 10 Single pouches)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102255 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWI TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2016MGP

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102262 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUSTotal Case Qty 250 TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUSTotal Case Qty 250 (120 Twin pouches + 10 Single pouches)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102279 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDE TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-6005MGP

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102286 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUSTotal Ca TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUSTotal Case Qty 250 (120 Twin pouches + 10 Single pouches)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102293 Catalog Number :

Device Description : SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 14G X 1" W/ STERIPICK INCLUDED WITH TW SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 14G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2004PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102309 Catalog Number :

Device Description : SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WITH SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WITH TWIN PACK BH-2005PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102316 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102323 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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