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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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SWAN-GANZ - 00690103000221

NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
Edwards Lifesciences LLC
040F4
In Commercial Distribution

  • 00690103000221 ()

  • EXTERIOR DIAMETER: 4F (1.33MM), USABLE LENGTH: 40CM, RECOMMENDED GUIDEWIRE SIZE: 0.016 IN (0.41 MM), MINIMUM INTRODUCER SIZE: 4.5F (1.50 MM)
040F4

  • Oximeter catheter, single-use

SWAN-GANZ - 00690103000207

NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
Edwards Lifesciences LLC
015F4
In Commercial Distribution

  • 00690103000207 ()

  • EXTERIOR DIAMETER: 4F (1.33MM), USABLE LENGTH: 25CM, RECOMMENDED GUIDEWIRE SIZE: 0.016 IN (0.41 MM), MINIMUM INTRODUCER SIZE: 4.5F (1.50 MM)
015F4

  • Oximeter catheter, single-use

PRESEP - 00690103176810

PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD
Edwards Lifesciences LLC
X3816S
Not in Commercial Distribution

  • 00690103176810 ()

  • Exterior Diameter: 8.5 F (2.8 mm), Usable Length: 16 cm, Number of Lumens: 3, Recommended Guidewire Size: 0.032" (0.81 mm)
X3816S

  • Oximeter catheter, single-use

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 - 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 - 00690103197549

PEDIASAT OXIMETRY CATHETER KIT
Edwards Lifesciences LLC
XT248KTP
In Commercial Distribution

  • 00690103197549 ()

  • USABLE LENGTH: 8 CM, NUMBER OF LUMENS: 2, EXTERIOR DIAMETER: 4.5F (1.50 MM)
XT248KTP

  • 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

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197594

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Edwards Lifesciences LLC
X3816ST
In Commercial Distribution

  • 00690103197594 ()

  • USABLE LENGTH: 16CM, EXTERIOR DIAMETER: 8.5F (2.8MM), RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81MM)
X3816ST

  • 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 - 00690103197556

PEDIASAT OXIMETRY CATHETER KIT
Edwards Lifesciences LLC
XT358KTP
In Commercial Distribution

  • 00690103197556 ()

  • EXTERIOR DIAMETER: 5.5F (1.83 MM), USABLE LENGTH: 8 CM, NUMBER OF LUMENS: 3
XT358KTP

  • Oximeter catheter, single-use
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