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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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EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197587

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Edwards Lifesciences LLC
X3820ST
In Commercial Distribution

  • 00690103197587 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 20CM, RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81 MM)
X3820ST

  • Oximeter catheter, single-use

PEDIASAT - 00690103197570

PEDIASAT OXIMETRY CATHETER KIT
Edwards Lifesciences LLC
XT245KTP
In Commercial Distribution

  • 00690103197570 ()

  • EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM)
XT245KTP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197563

PEDIASAT OXIMETRY CATHETER KIT
Edwards Lifesciences LLC
XT3515KTP
In Commercial Distribution

  • 00690103197563 ()

  • EXTERIOR DIAMETER: 5.5F (1.83MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.025 IN (0.64 MM)
XT3515KTP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197532

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT3515SP
In Commercial Distribution

  • 00690103197532 ()

  • EXTERIOR DIAMETER: 5.5F (1.83MM), USABLE LENGTH: 15CM, RECOMMENDED GUIDEWIRE SIZE: 0.025 IN (0.64 MM)
XT3515SP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197525

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT358SP
In Commercial Distribution

  • 00690103197525 ()

  • EXTERIOR DIAMETER: 5.5F (1.83MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.025 IN (0.64 MM)
XT358SP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197518

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT248SP
In Commercial Distribution

  • 00690103197518 ()

  • EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM)
XT248SP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197488

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT245SP
In Commercial Distribution

  • 00690103197488 ()

  • EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 5CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM)
XT245SP

  • Oximeter catheter, single-use

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197433

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Edwards Lifesciences LLC
X3820SP
In Commercial Distribution

  • 00690103197433 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 20CM, RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81 MM)
X3820SP

  • Oximeter catheter, single-use

EverFlex - 00821684033784

Self-Expanding Peripheral Stent System
Covidien LP
PRB35-06-060-080
In Commercial Distribution

  • 00821684033784 ()

  • Length: 60 Millimeter
  • Catheter Gauge: 6 French
  • Working Length,80,CM;Compatible Guidewire,.035,IN;Lumen Diameter,4.5 to 5.5,MM;
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 2 Millimeter


  • Peripheral artery stent, bare-metal

EverFlex - 00821684033777

Self-Expanding Peripheral Stent System
Covidien LP
PRB35-06-040-080
In Commercial Distribution

  • 00821684033777 ()

  • Catheter Gauge: 6 French
  • Length: 40 Millimeter
  • Working Length,80,CM;Compatible Guidewire,.035,IN;Lumen Diameter,4.5 to 5.5,MM;
  • Outer Diameter: 2 Millimeter
  • Outer Diameter: 6 Millimeter


  • Peripheral artery stent, bare-metal
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