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 - 00842289102132 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED W TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGPLB

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 - 00842289102149 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUSTotal Case TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL 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 - 00842289102156 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGP

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 - 00842289102163 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (12 TWINPACK FISTULA NEEDLE SET 16G X 1" 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 - 00842289102170 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED W TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGPLB

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 - 00842289102187 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUSTotal Case TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL 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 - 00842289102194 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGP

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 - 00842289102200 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (12 TWINPACK FISTULA NEEDLE SET 17G X 1" 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 - 00842289102217 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED W TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGPLB

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 - 00842289102224 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUSTotal Case TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL 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

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