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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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patchPrep tray Refill Kit
Smarthealth, Inc.
AL926
In Commercial Distribution

  • 00854498007559 ()
AL926

  • General laboratory container, reusable
patchPrep tray Starter Kit
Smarthealth, Inc.
AL925
In Commercial Distribution

  • 00854498007542 ()
AL925

  • General laboratory container, reusable
Universal Chamber Cover 50/box
Smarthealth, Inc.
AL910
In Commercial Distribution

  • 00854498007528 ()
  • 10854498007525 ()
AL910

  • General laboratory container, single-use
patchTransport, 50 trays
Smarthealth, Inc.
ALA1711
In Commercial Distribution

  • 00854498007085 ()
  • 10854498007082 ()
ALA1711

  • General laboratory container, single-use
The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.
Spectral Medical Inc
84018-01
In Commercial Distribution

  • B17384018010 ()
8401801

  • Multiple clinical chemistry analyser IVD, laboratory
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions performed and the user prompts. The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
Spectral Medical Inc
84007
In Commercial Distribution

  • B173840070 ()

  • Not Applicable
84007

  • Multiple clinical chemistry analyser IVD, laboratory
The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418.
Fresenius Kabi AG
4R4454W
In Commercial Distribution

  • 00810020441062 ()
4R4454W

  • Laboratory tubing welder
A disposable unit used for dispensing blood from a test tube.
PIXCELL MEDICAL TECHNOLOGIES LTD
HemoCup
In Commercial Distribution

  • 07290016991062 ()
  • 07290016991055 ()


  • Blood/blood culture specimen transfer spike IVD, manual
No Description
EQUASHIELD MEDICAL LTD
SK-20/2
In Commercial Distribution

  • 17290013484854 ()
  • 07290013484857 ()
  • 27290013484851 ()


  • Compounding transfer set
No Description
EQUASHIELD MEDICAL LTD
SK-10/2
In Commercial Distribution

  • 17290013484847 ()
  • 07290013484840 ()
  • 27290013484844 ()


  • Compounding transfer set
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