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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BioFlo - H965103028200

15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-820
In Commercial Distribution

  • H965103028201 ()
  • H965103028200 ()
  • 15051684025614 ()

  • Length: 32 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028190

15.5Fx28cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-819
In Commercial Distribution

  • H965103028191 ()
  • H965103028190 ()
  • 15051684025607 ()

  • Outer Diameter: 5.2 Millimeter
  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028180

15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-818
In Commercial Distribution

  • H965103028181 ()
  • H965103028180 ()
  • 15051684025591 ()

  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Length: 24 Centimeter


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028170

15.5Fx22cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-817
In Commercial Distribution

  • H965103028171 ()
  • H965103028170 ()
  • 15051684025584 ()

  • Outer Diameter: 5.2 Millimeter
  • Length: 22 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028160

15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-816
In Commercial Distribution

  • H965103028161 ()
  • H965103028160 ()
  • 15051684025577 ()

  • Catheter Gauge: 15.5 French
  • Length: 20 Centimeter
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028060

15.5Fx36cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-806
In Commercial Distribution

  • H965103028061 ()
  • H965103028060 ()
  • 15051684025430 ()

  • Needle Gauge: 18 Gauge
  • Outer Diameter: 5.2 Millimeter
  • Length: 36 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028050

15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-805
In Commercial Distribution

  • H965103028051 ()
  • H965103028050 ()
  • 15051684025423 ()

  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Length: 32 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028040

15.5Fx28cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-804
In Commercial Distribution

  • H965103028041 ()
  • H965103028040 ()
  • 15051684025416 ()

  • Needle Gauge: 18 Gauge
  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028030

15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-803
In Commercial Distribution

  • H965103028031 ()
  • H965103028030 ()
  • 15051684025409 ()

  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge
  • Length: 24 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028020

15.5Fx22cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-802
In Commercial Distribution

  • H965103028021 ()
  • H965103028020 ()
  • 15051684025393 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable

BioFlo - H965103028010

15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-801
In Commercial Distribution

  • H965103028011 ()
  • H965103028010 ()
  • 15051684025386 ()

  • Needle Gauge: 18 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 5.2 Millimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

Exodus - H965101510

Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10151
In Commercial Distribution

  • H965101511 ()
  • H965101510 ()
  • 15051684022507 ()

  • Outer Diameter: 3.4 Millimeter
  • Length: 25 Centimeter
  • Catheter Gauge: 10 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965101430

Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10143
In Commercial Distribution

  • H965101431 ()
  • H965101430 ()
  • 15051684022491 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100520

Array Multipurpose Drainage Catheter 10F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10052
In Commercial Distribution

  • H965100521 ()
  • H965100520 ()
  • 15051684022484 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 10 French
  • Outer Diameter: 3.4 Millimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100440

Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10044
In Commercial Distribution

  • H965100441 ()
  • H965100440 ()
  • 15051684022477 ()

  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter
  • Catheter Gauge: 8 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100320

10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10032
Not in Commercial Distribution

  • H965100321 ()
  • H965100320 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 10 French
  • Outer Diameter: 3.4 Millimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100080

10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10008
Not in Commercial Distribution

  • H965100081 ()
  • H965100080 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100030

8F x 25cm Tight Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10003
Not in Commercial Distribution

  • H965100031 ()
  • H965100030 ()

  • Length: 25 Centimeter
  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter


  • Closed-wound drain, non-bioabsorbable

ENVI - H965355100

STYLET 21G C 24CM SS
NAVILYST MEDICAL, INC.
35510_DI
In Commercial Distribution

  • H965355100 ()
  • H965355101 ()
  • 15051684023634 ()

  • Length: 24 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355090

NVI MINI STICK 6F X 20CM 21G TROCAR ECHO
NAVILYST MEDICAL, INC.
35-509
In Commercial Distribution

  • H965355090 ()
  • H965355091 ()
  • 15051684023627 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355080

NVI MINI STICK 6F X 20CM 21G CHIBA ECHO
NAVILYST MEDICAL, INC.
35-508
In Commercial Distribution

  • H965355080 ()
  • H965355081 ()
  • 15051684023610 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355070

NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G TROCAR
NAVILYST MEDICAL, INC.
35-507
In Commercial Distribution

  • H965355070 ()
  • H965355071 ()
  • 15051684023603 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355060

NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G CHIBA ECHO TIP
NAVILYST MEDICAL, INC.
35-506
In Commercial Distribution

  • H965355060 ()
  • H965355061 ()
  • 15051684023597 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355050

NEEDLE 18G X 15CM CHIBA STYLET
NAVILYST MEDICAL, INC.
35-505
In Commercial Distribution

  • H965355050 ()
  • H965355051 ()
  • 15051684023580 ()

  • Lumen/Inner Diameter: 0.95 Millimeter
  • Length: 15 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355040

NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP
NAVILYST MEDICAL, INC.
35-504
In Commercial Distribution

  • H965355040 ()
  • H965355041 ()
  • 15051684023573 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355030

NEEDLE 21G X 15CM CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
35-503
In Commercial Distribution

  • H965355030 ()
  • H965355031 ()
  • 15051684023566 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355020

GUIDEWIRE 0.018 X 65CM Ti/Tu
NAVILYST MEDICAL, INC.
35-502
Not in Commercial Distribution

  • H965355020 ()
  • H965355021 ()
  • 15051684023559 ()

  • Length: 65 Centimeter
  • Outer Diameter: 0.018 Inch


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355010

NVI SHEATH 6F X 20CM
NAVILYST MEDICAL, INC.
35-501
In Commercial Distribution

  • H965355010 ()
  • H965355011 ()
  • 15051684023542 ()

  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 20 Centimeter
  • NA


  • Vascular catheter introduction set, nonimplantable

Exodus - H965100020

8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10002
Not in Commercial Distribution

  • H965100021 ()
  • H965100020 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100010

8F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10001
Not in Commercial Distribution

  • H965100011 ()
  • H965100010 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable

BioFlo - H956PKM61014921S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM61014921S
In Commercial Distribution

  • H965PKM61014921S1 ()
  • H956PKM61014921S0 ()

  • Single
  • Catheter Gauge: 4 French
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter

BioFlo - H954PKM033511S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM033511S
In Commercial Distribution

  • H965PKM033511S1 ()
  • H954PKM033511S0 ()

  • Dual
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter

AngioDynamics - H965457860

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45786
In Commercial Distribution

  • H965457861 ()
  • H965457860 ()

  • Outer Diameter: 1.73 Millimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457850

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45785
In Commercial Distribution

  • H965457851 ()
  • H965457850 ()

  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457840

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45784
In Commercial Distribution

  • H965457841 ()
  • H965457840 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457830

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45783
In Commercial Distribution

  • H965457831 ()
  • H965457830 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457820

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45782
In Commercial Distribution

  • H965457821 ()
  • H965457820 ()

  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457810

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45781
In Commercial Distribution

  • H965457811 ()
  • H965457810 ()

  • Outer Diameter: 1.42 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457790

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45779
In Commercial Distribution

  • H965457791 ()
  • H965457790 ()

  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457780

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45778
In Commercial Distribution

  • H965457781 ()
  • H965457780 ()

  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Outer Diameter: 1.42 Millimeter
  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457770

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45777
In Commercial Distribution

  • H965457771 ()
  • H965457770 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 4 French
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457760

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45776
In Commercial Distribution

  • H965457761 ()
  • H965457760 ()

  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457750

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45775
In Commercial Distribution

  • H965457751 ()
  • H965457750 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457740

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45774
In Commercial Distribution

  • H965457741 ()
  • H965457740 ()

  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457730

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45773
In Commercial Distribution

  • H965457731 ()
  • H965457730 ()

  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457720

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45772
In Commercial Distribution

  • H965457721 ()
  • H965457720 ()

  • Outer Diameter: 1.73 Millimeter
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457710

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45771
In Commercial Distribution

  • H965457711 ()
  • H965457710 ()

  • Outer Diameter: 1.42 Millimeter
  • Length: 10 Centimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 4 French


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457700

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45770
In Commercial Distribution

  • H965457701 ()
  • H965457700 ()

  • Length: 10 Centimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457690

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45769
In Commercial Distribution

  • H965457691 ()
  • H965457690 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter
  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457680

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45768
In Commercial Distribution

  • H965457681 ()
  • H965457680 ()

  • Outer Diameter: 1.42 Millimeter
  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
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