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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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ECC 3/8" - 00607567205031

BO-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800m, Blood Transfer Bag 1000 ml - 2 spike ports, Better Bladder 3/8, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-TOP 22701
Not in Commercial Distribution

  • 00607567205031 ()
701052176

  • Cardiopulmonary bypass system blood tubing set

QuantorView - 08809466041112

QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration.
Digiray Corp.
1.2.1.466
In Commercial Distribution

  • 08809466041112 ()


  • Radiological PACS software

Welch Allyn, Inc. - 00732094266320

ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - A4 with spacer for writer tray); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); Ethernet LAN + WLAN (WPA2) + USBD; Standard storage (up to 40 ECGs); DICOM (Bidirectional com
WELCH ALLYN, INC.
901132
In Commercial Distribution

  • 00732094266320 ()
ELI280-DCB-AAFAD

  • Electrocardiograph, professional, multichannel

ECC 1/4" Pedi Pack - 00607567213418

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Venous Bag Reservoir 1900, BEQ-RF32 Rotaflow, BMU Cell Ven.1/4, Artierial Sensor 1/4" (BMU), Blood Microfilter System SQ40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric temp Probe
DATASCOPE CORP.
BEQ-TOP 38900
Not in Commercial Distribution

  • 00607567213418 ()
701056368R01

  • Cardiopulmonary bypass system blood tubing set

ECC 1/4" Pump Pack - 00607567212848

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BEQ-RF32 RotaFlow, CDI Sat Cell 1/4" System 100, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 41200
Not in Commercial Distribution

  • 00607567212848 ()
701063149R01

  • Cardiopulmonary bypass system blood tubing set

ECC 3/8" Pump Pack - Softline - 00607567212831

BO-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reserv. 800ml, Better Bladder 3/8, BO-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, Gas Filter
DATASCOPE CORP.
BO-TOP 41203
Not in Commercial Distribution

  • 00607567212831 ()
709000512R01

  • Cardiopulmonary bypass system blood tubing set

Pediatric Specialty Pack - 00607567212800

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, Better Bladder 3/8, 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, Gas Filter
DATASCOPE CORP.
BEQ-TOP 2203
Not in Commercial Distribution

  • 00607567212800 ()
701062614R01

  • Cardiopulmonary bypass system blood tubing set

ECC 3/8" Pump Pack - 00607567212565

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, 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, Gas Filter
DATASCOPE CORP.
BEQ-TOP 41201
Not in Commercial Distribution

  • 00607567212565 ()
701064867R01

  • Cardiopulmonary bypass system blood tubing set

ECC 3/8 Pump Pack - Softline - 00607567212213

BO-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 800ml Better Bladder 3/8 BO-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 Gas Filter
DATASCOPE CORP.
BO-TOP 41203
Not in Commercial Distribution

  • 00607567212213 ()
709000512

  • Cardiopulmonary bypass system blood tubing set

Custom Pack Neonates ECC + QPiD - 00607567212206

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, CDI Sat Cell 1/4" System 100, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BO-TOP 41202
Not in Commercial Distribution

  • 00607567212206 ()
709000510

  • Cardiopulmonary bypass system blood tubing set
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