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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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Merit Medical
00884450169797
In Commercial Distribution

  • 10884450169794 ()
  • 00884450169797 ()

  • French Size (F)-7F
  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-7F
WORLVI-75-5-62-07-RE

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284650
In Commercial Distribution

  • 10884450284657 ()
  • 00884450284650 ()

  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-5.5F
  • French Size (F)-5.5F
WORLVI-75-5-62-55-RE

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284643
In Commercial Distribution

  • 10884450284640 ()
  • 00884450284643 ()

  • Sheath Length (cm)-62 cm
  • French Size (F)-5.5F
  • Sheath Inner Diameter (ID) (F)-5.5F
WORLVI-75-5-62-55-MP

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284636
In Commercial Distribution

  • 10884450284633 ()
  • 00884450284636 ()

  • French Size (F)-5.5F
  • Sheath Length (cm)-62 cm
  • Sheath Inner Diameter (ID) (F)-5.5F
WORLVI-75-5-62-55-HS

  • Vascular catheter introduction set, nonimplantable
No Description
Merit Medical
00884450284582
In Commercial Distribution

  • 10884450284589 ()
  • 00884450284582 ()

  • Sheath Inner Diameter (ID) (F)-5.5F
  • Sheath Length (cm)-62 cm
  • French Size (F)-5.5F
WORLVI-75-5-62-55-HO

  • Vascular catheter introduction set, nonimplantable
Pudenz Peritoneal Catheter Barium Impregnated Stripe (Medium Pressure)
NATUS MEDICAL INCORPORATED
NT8501391
In Commercial Distribution


  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90cm (35 1/2") (all dimensions nominal)
NT8501391

  • Peritoneal/atrial cerebrospinal fluid catheter
Pudenz Peritoneal Catheter Barium Impregnated Stripe (Low Pressure)
NATUS MEDICAL INCORPORATED
NT8501390
In Commercial Distribution


  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90cm (35 1/2") (all dimensions nominal)
NT8501390

  • Peritoneal/atrial cerebrospinal fluid catheter
Integra® Pudenz Peritoneal Catheter Pudenz Peritoneal Catheter Barium Impregnated Stripe
Integra Lifesciences Corporation
NL8501391
In Commercial Distribution

  • 10381780024323 ()
  • M269NL85013911 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90cm (35 1/2") (all dimensions nominal)
NL8501391

  • Peritoneal/atrial cerebrospinal fluid catheter
Integra® Pudenz Peritoneal Catheter Pudenz Peritoneal Catheter Barium Impregnated Stripe
Integra Lifesciences Corporation
NL8501390
In Commercial Distribution

  • 10381780024316 ()
  • M269NL85013901 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90cm (35 1/2") (all dimensions nominal)
NL8501390

  • Peritoneal/atrial cerebrospinal fluid catheter
The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of a proprietary Venous Outflow Component and only one of the following options: • The Arterial Graft Component (not included) • The Adapter (a separate commercially available 6mm ID vascular graft is not included with the Adapter) The Venous Outflow Component (not included) has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip. The Adapter connects a 6mm ID vascular graft (not included) to the Venous Outflow Component. The Adapter (titanium) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter. See Instructions for Use for further details regarding the grafts permitted for use with the Adapter.
Artivion, Inc.
HERO 1004
Not in Commercial Distribution

  • 00877234000423 ()
HERO 1004

  • Arteriovenous shunt
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