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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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BARD® JAVID - 00801741090110

BARD® JAVID™ Carotid Bypass Shunt, 17F - 10F x 27.5cm
Bard Peripheral Vascular, Inc.
007714
Not in Commercial Distribution

  • 10801741090117 ()
  • 00801741090110 ()

  • External Diameter - 17 French to 10 French
  • Length: 27.5 Centimeter
007714

  • Carotid artery shunt

Glooko Mobile Application - 00855093008033

The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software

Kinesis QTUG - 05391542950003

QTUG consists of a device for assessment of mobility, falls risk and frailty in older adults through quantitative analysis of movement using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.
KINESIS
3.2.2
In Commercial Distribution

  • 05391542950003 ()


  • Gait analysis system

CANISTER SUPPORT BRACKET TO ATTACH CANISTER DIRECTLY TO A VACUUM REGULATOR - 40704411001332

CANISTER SUPPORT BRACKET TO ATTACH CANISTER DIRECTLY TO A VACUUM REGULATOR
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411001332 ()
  • 00704411001334 ()
443040415

  • General-purpose suction system, vacuum

PE anti-human CD22 - 00810034703996

URL: https://www.biolegend.com/en-us/products/pe-anti-human-cd22-27437
BIOLEGEND, INC.
987604
In Commercial Distribution

  • 00810034703996 ()

  • Total Volume: 500 Microliter
987604

  • Assay development analyte-specific reagent IVD

FITC anti-human IFN-Gamma - 00810034703965

URL: https://www.biolegend.com/en-us/products/fitc-anti-human-ifn-gamma-27384
BIOLEGEND, INC.
986708
In Commercial Distribution

  • 00810034703965 ()

  • Total Volume: 500 Microliter
986708

  • Assay development analyte-specific reagent IVD

Spark Violet™ 423 anti-human CD71 - 00810034703958

URL: https://www.biolegend.com/en-us/products/spark-violet-423-anti-human-cd71-27436
BIOLEGEND, INC.
985110
In Commercial Distribution

  • 00810034703958 ()

  • Total Volume: 500 Microliter
985110

  • Assay development analyte-specific reagent IVD

PE/Cyanine7 anti-human TNF-Alpha - 00810034703941

URL: https://www.biolegend.com/en-us/products/pe-cyanine7-anti-human-tnf-alpha-27385
BIOLEGEND, INC.
986804
In Commercial Distribution

  • 00810034703941 ()

  • Total Volume: 500 Microliter
986804

  • Assay development analyte-specific reagent IVD

PE anti-human CD73 - 00810034703934

URL: https://www.biolegend.com/en-us/products/pe-anti-human-cd73-27438
BIOLEGEND, INC.
989914
In Commercial Distribution

  • 00810034703934 ()

  • Total Volume: 500 Microliter
989914

  • Assay development analyte-specific reagent IVD

PE anti-human Granzyme B - 00810034703927

URL: https://www.biolegend.com/en-us/products/pe-anti-human-granzyme-b-27386
BIOLEGEND, INC.
989910
In Commercial Distribution

  • 00810034703927 ()

  • Total Volume: 500 Microliter
989910

  • Assay development analyte-specific reagent IVD
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