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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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BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BEQ-TOP 44802
Not in Commercial Distribution

  • 00607567209169 ()
701068938

  • Cardiopulmonary bypass system blood tubing set
Agilis™ NxT Steerable Introducer: Bi-Directional, Medium Curl 22.4 mm, 71 cm, 8.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff
STERILMED, INC.
STJ408310
Not in Commercial Distribution

  • 10888551044929 ()
STJ408310

  • Cardiac transseptal access set
Gas Sampling Line .060" ID x .120" OD x 60" Length PVCwith Male Luer Lock Connector5 micron Hydrophobic Filter and MSL Connector
SALTER LABS
ZML-9021-MSL-1
In Commercial Distribution

  • 10607411916929 ()
  • 00607411916922 ()
ZML-9021-MSL-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
Gas Sampling Line .047" ID x 96" length PE/PVC with Male/Female Luer Lock Connectors, 5.0um Hydrophobic Filter, PTFE, 25 mm
SALTER LABS
ZML-9441-1
In Commercial Distribution

  • 00607411940613 ()
ZML-9441-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
Kits Contents : Catheter 4FR OD 1.45mmx200mm; J guidewire OD 0.64mmx450mm, Steel Needle Introducer 17G OD 1.4mmx70mm, Dilator 5FR OD 1.7mm ID 0.66mm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681649
In Commercial Distribution

  • 50886333616492 ()
  • 00886333616497 ()

  • Catheter 4FR OD 1.45mmx200mm
681649

  • Vascular catheter introduction set, nonimplantable
Kits Contents : Catheter 3FR OD 1.10mmx150mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Dilator 4FR OD 1.27mm ID 0.51mm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681639
In Commercial Distribution

  • 50886333616393 ()
  • 00886333616398 ()

  • Catheter 3FR OD 1.10mmx150mm
681639

  • Vascular catheter introduction set, nonimplantable
Kits Contents : Catheter 2.5FR OD 0.9mmx100mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm;Dilator 4FR OD 1.27mm ID 0.51mm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681614
In Commercial Distribution

  • 50886333616140 ()
  • 00886333616145 ()

  • Catheter 2.5FR OD 0.9mmx100mm
681614

  • Vascular catheter introduction set, nonimplantable
Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x ID 2.90mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.4x70mm, stopcock
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680156
In Commercial Distribution

  • 50886333601566 ()
  • 00886333601561 ()

  • Catheter 9Fr
680156

  • Haemostasis valve
microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.
FHC, INC.
FC1012-00153
Not in Commercial Distribution

  • 00873263001530 ()
FC1012

  • Intracerebral cannula, implantable
  • Neurosurgical micro targeting drive
microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.
FHC, INC.
FC1012-00131
Not in Commercial Distribution

  • 00873263001318 ()
FC1012

  • Neurosurgical micro targeting drive
  • Intracerebral cannula, implantable
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