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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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Dialysate Sampling Port Kit
MOLDED PRODUCTS, INC.
MPC-180
In Commercial Distribution

  • B144MPC1802 ()
MPC-180

  • Haemodialysis system, institutional
No Description
MONOBIND, INC.
IN002
In Commercial Distribution

  • 00816870020044 ()
IN002

  • Microplate washer IVD
No Description
Roche Molecular Systems, Inc.
08106495001
Not in Commercial Distribution

  • 07613336160176 ()
08106495001

  • Slide-mounted-tissue dissection system IVD
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
Slide Print Cartridge Color; 6/case
SAKURA FINETEK U.S.A., INC.
9031
In Commercial Distribution

  • 10615233082463 ()
  • 00615233082466 ()
9031

  • Microscope slide labelling cartridge IVD
Slide and Cassette Print Cartridge Black; 6/case
SAKURA FINETEK U.S.A., INC.
9030
In Commercial Distribution

  • 10615233082456 ()
  • 00615233082459 ()
9030

  • Microscope slide labelling cartridge IVD
An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test.
DAXOR CORPORATION
SC25 MK2
In Commercial Distribution

  • B641SC25MK20 ()


  • Blood volume analyser IVD
Specimen Infusion Valve (SIV) 0.760 mm ID Metering Line
NICO CORPORATION
NN-8039
In Commercial Distribution

  • 10816744028395 ()
  • 00816744028398 ()


  • Surgical suction system Y-piece valve-connector
Specimen Infusion Valve (SIV) 0.5 mm Metering Line
NICO CORPORATION
NN-8016
In Commercial Distribution

  • 10816744028166 ()
  • 00816744028169 ()


  • Surgical suction system Y-piece valve-connector
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