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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AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
MAXQ AI LTD
V2.3 and subsequent minor V2.x releases
In Commercial Distribution

  • 00860001219531 ()


  • Radiology DICOM image processing application software
ANTIFUNGAL QC LEVEL 2
UTAK LABORATORIES, INC.
ANTIF QC 2 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC2V2LPFTF5 ()
  • B800ANTIFQC2V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 2 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
AMPHETAMINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
AMPH+ 2 WB 2PT F V2 SDHL
In Commercial Distribution

  • B800AMPH2WB2PTFV2SDHL5 ()
  • B800AMPH2WB2PTFV2SDHL0 ()

  • Total Volume: 1 Milliliter
AMPH+ 2 WB 2PT F V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
AMPH+ 1 WB 2PT F V2 SDHL
In Commercial Distribution

  • B800AMPH1WB2PTFV2SDHL5 ()
  • B800AMPH1WB2PTFV2SDHL0 ()

  • Total Volume: 1 Milliliter
AMPH+ 1 WB 2PT F V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGAL QC LEVEL 3
UTAK LABORATORIES, INC.
ANTIF QC 3 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC3V2LPFTF5 ()
  • B800ANTIFQC3V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 3 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 1
UTAK LABORATORIES, INC.
ANTIF QC 1 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC1V2LPFTF5 ()
  • B800ANTIFQC1V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 1 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
VOLATILES QC LEVEL 2
UTAK LABORATORIES, INC.
VOL QC 2 V2 U 2-PT LSA
In Commercial Distribution

  • B800VOLQC2V2U2PTLSA5 ()
  • B800VOLQC2V2U2PTLSA0 ()

  • Total Volume: 10 Milliliter
VOL QC 2 V2 U 2-PT LSA

  • Multiple drugs of abuse IVD, control
VOLATILES QC LEVEL 1
UTAK LABORATORIES, INC.
VOL QC 1 V2 U 2-PT LSA
In Commercial Distribution

  • B800VOLQC1V2U2PTLSA5 ()
  • B800VOLQC1V2U2PTLSA0 ()

  • Total Volume: 10 Milliliter
VOL QC 1 V2 U 2-PT LSA

  • Multiple drugs of abuse IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 V V2 S F UCSD
In Commercial Distribution

  • B800MET2VV2SFUCSD5 ()
  • B800MET2VV2SFUCSD0 ()

  • Total Volume: 3 Milliliter
MET 2 V V2 S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
METALS LEVEL 1
UTAK LABORATORIES, INC.
MET 1 V V2 S F UCSD
In Commercial Distribution

  • B800MET1VV2SFUCSD5 ()
  • B800MET1VV2SFUCSD0 ()

  • Total Volume: 3 Milliliter
MET 1 V V2 S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 6
UTAK LABORATORIES, INC.
ETG+ CAL 6 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL6V2UFUCSF5 ()
  • B800ETGCAL6V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 6 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL5V2UFUCSF5 ()
  • B800ETGCAL5V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 5 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 4
UTAK LABORATORIES, INC.
ETG+ CAL 4 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL4V2UFUCSF5 ()
  • B800ETGCAL4V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 4 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 3
UTAK LABORATORIES, INC.
ETG+ CAL 3 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL3V2UFUCSF5 ()
  • B800ETGCAL3V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 3 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
ETG+ CAL 2 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL2V2UFUCSF5 ()
  • B800ETGCAL2V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 2 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
ETG+ CAL 1 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL1V2UFUCSF5 ()
  • B800ETGCAL1V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 1 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
Vascular Table with Fowler Backrest, Standard; 26" Width; 240V Electric Ultrasound (EA) Ergonomics Advantage Series
OAKWORKS, INC.
EA Vascular Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025606 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Right Back Support; 30" Width; 240V Electric USV2R0XXXXOSXXXX Ultrasound (EA) Ergonomics Advantage Series
OAKWORKS, INC.
EA Vascular Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025590 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Right and Left Back Supports; 30" Width; 240V Electric Ultrasound (EA) Ergonomics Advantage Series
OAKWORKS, INC.
EA Vascular Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025583 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Cardio with Right back Support; 30" Width; 240V Electric Ultrasound (EA) Ergonomics Advantage Series
OAKWORKS, INC.
EA Vascular Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025576 ()


  • Examination/treatment table, line-powered
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