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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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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 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 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 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 KIT
Edwards Lifesciences LLC
X3820KT
In Commercial Distribution

  • 00690103197457 ()

  • EXTERIOR DIAMETER:8.5F (2.8MM), USABLE LENGTH:20 CM, MAXIMUM GUIDEWIRE SIZE: 0.032IN (0.81 MM)
X3820KT

  • Oximeter catheter, single-use
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT
Edwards Lifesciences LLC
X3816KT
In Commercial Distribution

  • 00690103197440 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 16CM, RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81 MM)
X3816KT

  • Oximeter catheter, single-use
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
EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
Edwards Lifesciences LLC
XA3816SAFKT
In Commercial Distribution

  • 00690103197181 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 16CM, NUMBER OF LUMENS: 3, MAXIMUM GUIDEWIRE DIAMETER: 0.032 IN (0.81 MM)
XA3816SAFKT

  • Oximeter catheter, single-use
Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.
DRAGON HEART MEDICAL, INC.
R002
Not in Commercial Distribution

  • B346R0021 ()
R002

  • Electronic gravity infusion controller administration set
20" Extension Set with Flow Controller
NEXUS MEDICAL, LLC
N2523
In Commercial Distribution

  • 30815879020216 ()
  • 10815879020212 ()


  • Electronic gravity infusion controller administration set
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