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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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Quantum - 05060434422019

Quantum Flow Sensor - ID 1/2" x Wall 3/32"(OD11/16") 0.75m
SPECTRUM MEDICAL LIMITED
QFS5-ST-075
In Commercial Distribution

  • 05060434422019 ()
51-000079-00

  • Cardiopulmonary bypass system air bubble/fluid level detector

High-Temperature Silicone Rubber Irrigation Tubing,Semi-Clear Blue - D9288330250240

High-Temperature Silicone Rubber Irrigation Tubing,Semi-Clear Blue, 1mm ID, 3mm OD, 24" Length
W.H. Holden, Inc.
83-3025-024
In Commercial Distribution

  • D9288330250240 ()


  • Surgical irrigation/aspiration cannula, illuminating, reusable

AirLife™ - 10889483599099

AirLife™ Non-Heated Ventilator Circuit Elbow With 22m ID/OD and Temperature Port
AIRLIFE
FG65-4225
In Commercial Distribution

  • 30889483599093 ()
  • 10889483599099 ()
FG65-4225

  • Ventilator breathing circuit, single-use

SmartFlow - 00850047354112

SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip
Clearpoint Neuro, Inc.
NGS-NC-02-EE
In Commercial Distribution

  • 00850047354112 ()
NGS-NC-02-EE

  • Intracerebral cannula, nonimplantable, single-use

SmartFlow - 00850047354105

SmartFlow Neuro Cannula, 16 ga, .008" ID x 4 ft x 18mm tip
Clearpoint Neuro, Inc.
NGS-NC-01-EE
In Commercial Distribution

  • 00850047354105 ()
NGS-NC-01-EE

  • Intracerebral cannula, nonimplantable, single-use

Rapid Response Universal Pack - 00607567213128

BO-HMOD 70000-USA Adult Quadrox iD,Venous Bag Reservoir 1900, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-TOP 13901
In Commercial Distribution

  • 00607567213128 ()
701054874R02

  • Cardiopulmonary bypass system blood tubing set

SAMMC ECC Q-D & RF with 3/8 AV Loop - 00607567212954

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml,BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 34100
In Commercial Distribution

  • 00607567212954 ()
701054136R01

  • Cardiopulmonary bypass system blood tubing set

ECC Pack - 00607567212282

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 32200
Not in Commercial Distribution

  • 00607567212282 ()
701053319R01

  • Cardiopulmonary bypass system blood tubing set

Small Patient Circuit 1/4” with QiD - 00607567212268

BO-HMOD 70000-USA Adult Quadrox iD, Better Bladder 1/4, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 20705
In Commercial Distribution

  • 00607567212268 ()
701053486R01

  • Cardiopulmonary bypass system blood tubing set

Small Patient Circuit 3/8" with QiD - 00607567212251

BO-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BO-RF32 Rotaflow, Gas Filter
DATASCOPE CORP.
BO-TOP 20700
Not in Commercial Distribution

  • 00607567212251 ()
701050966R01

  • Cardiopulmonary bypass system blood tubing set

N/A - 00607411401350

GAS SAMPLE LINE, .047" ID x 120" Length PE/PVC Male/Female connector
SALTER LABS
ZML-9640B-125
In Commercial Distribution

  • 10607411401357 ()
  • 00607411401350 ()
ZML-9640B-125

  • Nasal oxygen cannula, carbon-dioxide-sampling

CP Rapid Prime Pack - 00607567210875

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 39500
In Commercial Distribution

  • 00607567210875 ()
701062313R01

  • Cardiopulmonary bypass system blood tubing set

Rapid Response Uni Pck wo B Bladder - 00607567210592

BO-HMOD 70000-USA Adult Quadrox iD, BO-Softshell Venous Reser. 1900ml, BO-RF32 RotaFlow, Gas Filter.
DATASCOPE CORP.
BO-TOP 13901
Not in Commercial Distribution

  • 00607567210592 ()
709000346

  • Cardiopulmonary bypass system blood tubing set

1/4" Custom Pack + "QPiD" - 00607567203716

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Better Bladder 1/4, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 28004
Not in Commercial Distribution

  • 00607567203716 ()
701052608

  • Cardiopulmonary bypass system blood tubing set

ECC Pack - 00607567203358

BEQ-HMOD 70000-USA Adult Quadrox iD, BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filter.
DATASCOPE CORP.
BEQ-TOP 21902
Not in Commercial Distribution

  • 00607567203358 ()
701055522

  • Cardiopulmonary bypass system blood tubing set

N/A - 00607411940422

Gas Sampling Line .060" ID x 120" Length PVCwith Male Luer Lock Connectors
SALTER LABS
ZML-9521-E-MSL-1
In Commercial Distribution

  • 10607411940429 ()
  • 00607411940422 ()
ZML-9521-E-MSL-1

  • Nasal oxygen cannula, carbon-dioxide-sampling

N/A - 00607411911682

Gas Sampling Line .050" ID x 120" Length PVCMale/Female Luer Lock Connectors
SALTER LABS
ZML-9630-1
Not in Commercial Distribution

  • 10607411911689 ()
  • 00607411911682 ()
ZML-9630-1

  • Nasal oxygen cannula, carbon-dioxide-sampling

N/A - 00607411911668

Gas Sampling Line .060" ID x 120" Length PVCMale/Female Luer Lock Connectors
SALTER LABS
ZML-9620-1
Not in Commercial Distribution

  • 10607411911665 ()
  • 00607411911668 ()
ZML-9620-1

  • Nasal oxygen cannula, carbon-dioxide-sampling

N/A - 00607411911651

Gas Sampling Line .060" ID x 120" Length PVCwith Male Luer Lock Connectors
SALTER LABS
ZML-9520-1
Not in Commercial Distribution

  • 10607411911658 ()
  • 00607411911651 ()
ZML-9520-1

  • Nasal oxygen cannula, carbon-dioxide-sampling

PULL THRU™ Cleaning Brush - 09421028490580

Channel cleaning brush, channel ID 1.0-1.2mm, length 2200mm, 3 x 360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
ZZ0112+60+0+2200 Refill pack
In Commercial Distribution

  • 09421028493444 ()
  • 09421028490580 ()
ZZ0112+60+0+2200

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028492973

6 x Channel cleaning brush, channel ID 1.0mm-1.2mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD0112+6+0+610/75 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028492973 ()
  • 09421028493468 ()
CSD0112+6+0+610/75

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490764

Channel cleaning brush, channel ID 1.4-2.6mm, length 2200mm, 3 x 360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
ZZ1426+60+0+2200 Refill pack
In Commercial Distribution

  • 09421028493437 ()
  • 09421028490764 ()
ZZ1426+60+0+2200

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490566

Channel cleaning brush, channel ID 1.0-1.2mm, length 2200mm, 3 x 360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
ZZ0112+180+0+2200 Refill pack
In Commercial Distribution

  • 09421028493444 ()
  • 09421028490566 ()
ZZ0112+180+0+2200

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490535

6 x Channel cleaning brush, channel ID 1.4mm-2.6mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD1426+1+0+610/40 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028493475 ()
  • 09421028490535 ()
CSD1426+1+0+610/40

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490443

6 x Channel cleaning brush, channel ID 13.0mm-15.0mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD1315+6+0+610/96 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028493512 ()
  • 09421028490443 ()
CSD1315+6+0+610/96

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490436

6 x Channel cleaning brush, channel ID 9.0mm-12.0mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD0912+6+0+610/09 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028493505 ()
  • 09421028490436 ()
CSD0912+6+0+610/09

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490429

6 x Channel cleaning brush, channel ID 6.0mm-8.0mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD0608+6+0+610/27 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028493499 ()
  • 09421028490429 ()
CSD0608+6+0+610/27

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490412

6 x Channel cleaning brush, channel ID 3.0mm-5.0mm, length 610mm, 4x360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
CSD0305+6+0+610/80 - CSSD Instrument cleaning brush
In Commercial Distribution

  • 09421028493482 ()
  • 09421028490412 ()
CSD0305+6+0+610/80

  • Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush - 09421028490399

Channel cleaning brush, channel ID 2.8-5.0mm, length 230mm, 2 x 360 degree wipers
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
ZZPT2850+60+0+230 PUSH THRU
In Commercial Distribution

  • 09421028493420 ()
  • 09421028490399 ()
ZZPT2850+60+0+230

  • Surgical instrument/endoscope cleaning utensil, single-use

N/A - 00884908028799

21GA (0.85MM OD;0.60MM ID) X 5 CM SAFETY NEEDLE W/ECHO TIP
Medical Components, Inc.
MC215S
Not in Commercial Distribution

  • 50884908028794 ()
  • 00884908028799 ()


  • Vascular catheter introduction needle
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