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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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CAREFLOW(TM) 1 LUMEN 5FR X 150MM - 00886333616701

Kits Contents : Catheter 5FR OD 1.75mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm & Floswitch(TM).
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681670
In Commercial Distribution

  • 50886333616706 ()
  • 00886333616701 ()

  • Catheter 5FR OD 1.75mmx150mm
681670

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 3 LUMEN 5FR X 60MM - 00886333616299

Kits Contents : Catheter 5FR OD 1.75mmx60mm; J guidewire OD 0.64mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 18G OD1.2mmx60mm, Dilator 6FR OD 2.03mm ID 0.66mm & Floswitch(TM).
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681629
In Commercial Distribution

  • 50886333616294 ()
  • 00886333616299 ()

  • Catheter 5FR OD 1.75mmx60mm
681629

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 2 LUMEN 5FR X 60MM - 00886333616282

Kits Contents : Catheter 5FR OD 1.75mmx60mm; J guidewire OD 0.64mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 18G OD1.2mmx60mm, Dilator 6FR OD 2.03mm ID 0.66mm & Floswitch(TM)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681628
In Commercial Distribution

  • 50886333616287 ()
  • 00886333616282 ()

  • Catheter 5FR OD 1.75mmx60mm
681628

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 3 LUMEN 5FR X 100MM - 00886333616183

Kits Contents : Catheter 5FR OD 1.75mmx100mm; J guidewire OD 0.64mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 18G OD1.2mmx60mm, Dialator 6FR OD 2.03mm ID 0.66mm & Floswitch(TM)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681618
In Commercial Distribution

  • 50886333616188 ()
  • 00886333616183 ()

  • Catheter 5FR OD 1.75mmx100mm
681618

  • Vascular catheter introduction set, nonimplantable

Canvas Dx - 00860007260605

Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution

  • 00860007260605 ()


  • Neurodevelopmental disorder interpretive software

ECC 3/8” Pump Pack - 00607567213166

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8
DATASCOPE CORP.
BEQ-TOP 41201
Not in Commercial Distribution

  • 00607567213166 ()
701064867R02

  • Cardiopulmonary bypass system blood tubing set

Adult ECC - 00607567213111

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, CDI Sai Cell 3/8" System 100, Blood Microfilter System SQ 40 S, Prebypass Filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 24202
In Commercial Distribution

  • 00607567213111 ()
701054295R02

  • Cardiopulmonary bypass system blood tubing set

ECC Pack 1/4" with Roller - 00607567206335

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 27609
Not in Commercial Distribution

  • 00607567206335 ()
701065504

  • Cardiopulmonary bypass system blood tubing set

Custom Pack Neonates ECC+QPiD - 00607567203402

BEQ-HMOD 30000-USA Pediatric Quadrox iD Softshell Venous Reser. 800ml Better Bladder 1/4 Blood Microfilter System SQ 40 S Prebypass filter w/o Vent Porous Media 3/8x3/8 Gas Filter Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 28601
Not in Commercial Distribution

  • 00607567203402 ()
701051935

  • Cardiopulmonary bypass system blood tubing set

CAREFLOW(TM) 3 LUMEN 7FR X 300MM - 00886333617289

Kits Contents : Catheter 7FR OD 2.40mmx300mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm & Floswitch(TM).
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681728
In Commercial Distribution

  • 50886333617284 ()
  • 00886333617289 ()

  • Catheter 7FR OD 2.40mmx300mm
681728

  • Vascular catheter introduction set, nonimplantable
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