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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Prebent Rod, Line, Ø5.5x55 mm
NEXXT SPINE, LLC
10-36-5555
In Commercial Distribution

  • 00889929010679 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Prebent Rod, Line, Ø5.5x50 mm
NEXXT SPINE, LLC
10-36-5550
In Commercial Distribution

  • 00889929010662 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Prebent Rod, Line, Ø5.5x40 mm
NEXXT SPINE, LLC
10-36-5540
In Commercial Distribution

  • 00889929010655 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Prebent Rod, Line, Ø5.5x35 mm
NEXXT SPINE, LLC
10-36-5535
In Commercial Distribution

  • 00889929010648 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Prebent Rod, Line, Ø5.5x30 mm
NEXXT SPINE, LLC
10-36-5530
In Commercial Distribution

  • 00889929010631 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Prebent Rod, Line, Ø5.5x25 mm
NEXXT SPINE, LLC
10-36-5525
In Commercial Distribution

  • 00889929010624 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
  • Prebent, Line


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x600 mm
NEXXT SPINE, LLC
10-37-55600
In Commercial Distribution

  • 00889929023600 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 600 Millimeter
  • Straight, Line


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x400 mm
NEXXT SPINE, LLC
10-37-55400
In Commercial Distribution

  • 00889929023594 ()

  • Straight, Line
  • Length: 400 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x200 mm
NEXXT SPINE, LLC
10-37-55200
In Commercial Distribution

  • 00889929023587 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 200 Millimeter
  • Straight, Line


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x150 mm
NEXXT SPINE, LLC
10-37-55150
In Commercial Distribution

  • 00889929023570 ()

  • Straight, Line
  • Length: 150 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x140 mm
NEXXT SPINE, LLC
10-37-55140
In Commercial Distribution

  • 00889929023563 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 140 Millimeter
  • Straight, Line


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x130 mm
NEXXT SPINE, LLC
10-37-55130
In Commercial Distribution

  • 00889929023556 ()

  • Straight, Line
  • Length: 130 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Straight Rod, Line, Ø5.5x120 mm
NEXXT SPINE, LLC
10-37-55120
In Commercial Distribution

  • 00889929023549 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 120 Millimeter
  • Straight, Line


  • Bone-screw internal spinal fixation system rod
ArgoTrans Model 2/Macro 9" Line, Stopcock
ARGON MEDICAL DEVICES, INC.
041582505A
Not in Commercial Distribution

  • 20886333201703 ()
  • 00886333201709 ()

  • 9" Line
041582505A

  • Invasive blood pressure transducer set
Pressure Monitoring Lines 8Ft. M/M Pressure Monitoring Injection Line
ARGON MEDICAL DEVICES, INC.
040208005A
In Commercial Distribution

  • 20886333201253 ()
  • 00886333201259 ()

  • 8Ft. Line
040208005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Opaque PE Tubing 8Ft. Line w/Male Luer Lock Connectors on each end
ARGON MEDICAL DEVICES, INC.
040208001A
In Commercial Distribution

  • 20886333201246 ()
  • 00886333201242 ()

  • 8Ft. Line
040208001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Line 6' M/M w/ Vented Covers
ARGON MEDICAL DEVICES, INC.
040206105A
Not in Commercial Distribution

  • 20886333201222 ()
  • 00886333201228 ()

  • 6' Line
040206105A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing Tubing 4Ft. Line w/Male Luer Lock Connectors on each End
ARGON MEDICAL DEVICES, INC.
040204001A
In Commercial Distribution

  • 20886333201154 ()
  • 00886333201150 ()

  • 4Ft. Line
040204001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines 3Ft. M/M
ARGON MEDICAL DEVICES, INC.
040203005A
Not in Commercial Distribution

  • 20886333201123 ()
  • 00886333201129 ()

  • 3ft. line
040203005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 3Ft. Line w/Male Luer Lock Connectors on each End
ARGON MEDICAL DEVICES, INC.
040203001A
Not in Commercial Distribution

  • 20886333201116 ()
  • 00886333201112 ()

  • 3Ft. Line
040203001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 2Fr. Line w/Male Luer Lock Connectors on Each End
ARGON MEDICAL DEVICES, INC.
040202001A
In Commercial Distribution

  • 20886333201093 ()
  • 00886333201099 ()

  • 2Ft. Line
040202001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines 6" M/M
ARGON MEDICAL DEVICES, INC.
040200005A
Not in Commercial Distribution

  • 20886333201079 ()
  • 00886333201075 ()

  • 6" Line
040200005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 6" Line w/Male Luer Lock Connectors on each End
ARGON MEDICAL DEVICES, INC.
040200001A
Not in Commercial Distribution

  • 20886333201062 ()
  • 00886333201068 ()

  • 6" Line
040200001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 8Ft. Line w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040108001A
Not in Commercial Distribution

  • 20886333201000 ()
  • 00886333201006 ()

  • 8Ft. Line
040108001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Injection Line 6Ft. M/F
ARGON MEDICAL DEVICES, INC.
040106005A
In Commercial Distribution

  • 20886333200973 ()
  • 00886333200979 ()

  • 6Ft. line
040106005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Line 4’ M/F w/Vented Covers
ARGON MEDICAL DEVICES, INC.
040104105A
Not in Commercial Distribution

  • 20886333200928 ()
  • 00886333200924 ()

  • 4' Line
040104105A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 4Ft. Line w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040104001A
In Commercial Distribution

  • 20886333200904 ()
  • 00886333200900 ()

  • 4ft. Line
040104001A

  • Fluid transfer set, general-purpose
Pressure Opaque PE Tubing 3Ft. Line with Male and Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040103001A
In Commercial Distribution

  • 20886333200874 ()
  • 00886333200870 ()

  • 3ft Line
040103001A

  • Fluid transfer set, general-purpose
Contrast Media Set Vented Spike IV Set with 72" Line
ARGON MEDICAL DEVICES, INC.
039829999A
In Commercial Distribution

  • 20886333200768 ()
  • 00886333200764 ()

  • 72" Line
039829999A

  • Fluid transfer set, general-purpose
Bifurcate IV Set
ARGON MEDICAL DEVICES, INC.
039820599A
In Commercial Distribution

  • 20886333200737 ()
  • 00886333200733 ()

  • 6" Line
039820599A

  • Fluid transfer set, general-purpose
StatStrip GLU Meter with Quick Reference Guide Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480517079 ()
  • 00385480517072 ()
51707

  • Glucose monitoring system IVD, point-of-care
StatSensor Creatinine Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480506684 ()
  • 00385480506687 ()
50668

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatStrip LAC Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480474884 ()
  • 00385480474887 ()
47488

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatStrip Glu Meter and Quick Reference Guide Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480471432 ()
  • 00385480471435 ()
47143

  • Glucose monitoring system IVD, point-of-care
StatStrip Xpress GLU Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Ejector
In Commercial Distribution

  • 10385480467992 ()
  • 00385480467995 ()
46799

  • Glucose monitoring system IVD, point-of-care
StatStrip GLU Meter with Quick Reference Guide Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480458860 ()
  • 00385480458863 ()
45886

  • Glucose monitoring system IVD, point-of-care
StatSensor Creatinine Meter with Quick Reference Guide - Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480453353 ()
  • 00385480453356 ()
45335

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatSensor Creatinine Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480440520 ()
  • 00385480440523 ()
44052

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatStrip GLU Meter and Quick Reference Guide Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480437735 ()
  • 00385480437738 ()
43773

  • Glucose monitoring system IVD, point-of-care
Remanufactured Stat Profile pHOx Ultra Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution

  • 10385480420188 ()
  • 00385480420181 ()
42018

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Stat Profile pHOx Ultra CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420171 ()
  • 00385480420174 ()
42017

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Ultra ABG Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution

  • 10385480420140 ()
  • 00385480420143 ()
42014

  • Blood gas analyser IVD, point-of-care
Stat Profile pHOx Ultra Co-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420133 ()
  • 00385480420136 ()
42013

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Stat Profile pHOx Plus C Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX PLUS C
In Commercial Distribution

  • 10385480380253 ()
  • 00385480380256 ()
38025

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Stat Profile Critical Care Xpress CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
CCX CO OX
In Commercial Distribution

  • 10385480375556 ()
  • 00385480375559 ()
37555

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile Critical Care Express CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
CCX CO OX
In Commercial Distribution

  • 10385480374139 ()
  • 00385480374132 ()
37413

  • Co-oximetry analyser IVD, point-of-care
Remanufactured Stat Profile Phox Basic Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX BASIC
In Commercial Distribution

  • 10385480355404 ()
  • 00385480355407 ()
35540

  • Blood gas analyser IVD, point-of-care
Stat Profile pHOx Plus C Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX PLUS C
In Commercial Distribution

  • 10385480355367 ()
  • 00385480355360 ()
35536

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile PHOX BASIC Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX BASIC
In Commercial Distribution

  • 10385480353493 ()
  • 00385480353496 ()
35349

  • Co-oximetry analyser IVD, point-of-care
Remanufactured Stat Profile pHOx Plus L Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 10385480347171 ()
  • 00385480347174 ()
34717

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
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