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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PANEL 02 COC150/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020191
In Commercial Distribution

  • 10858904006539 ()
  • 00858904006532 ()
DOA-124-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 01 MAMP 500
REDWOOD TOXICOLOGY LABORATORY, INC.
011020190
In Commercial Distribution

  • 10858904006522 ()
  • 00858904006525 ()
DMA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 01 COC 150
REDWOOD TOXICOLOGY LABORATORY, INC.
011020189
In Commercial Distribution

  • 10858904006515 ()
  • 00858904006518 ()
DOA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 OXYCODONE (OXY)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020037
In Commercial Distribution

  • 10858904006119 ()
  • 00858904006112 ()
DOX-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 OPIATES (OPI)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020003
In Commercial Distribution

  • 10858904006065 ()
  • 00858904006068 ()
DMO-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 COCAINE (COC)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020001
In Commercial Distribution

  • 10858904006041 ()
  • 00858904006044 ()
DCO-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 BENZODIAZEPINE (BZO)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020022
In Commercial Distribution

  • 10858904006034 ()
  • 00858904006037 ()
DBZ-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 BARBITURATE (BAR)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020019
In Commercial Distribution

  • 10858904006027 ()
  • 00858904006020 ()
DBA-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Post Mount Heavy Panel
Conmed Corporation
VP8565
In Commercial Distribution

  • 10845854028995 ()
VP8565

  • Medical device integration rack
PANEL 2 COC/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020006
In Commercial Distribution

  • 10858904006171 ()
  • 00858904006174 ()
DOA-124-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 2 COC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020005
In Commercial Distribution

  • 10858904006140 ()
  • 00858904006143 ()
DOA-224-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 2 M-AMP/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020030
In Commercial Distribution

  • 10858904006133 ()
  • 00858904006136 ()
DOA-824-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 METHADONE (MTD)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020020
In Commercial Distribution

  • 10858904006072 ()
  • 00858904006075 ()
DMT-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 ECSTASY (MDMA)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020036
In Commercial Distribution

  • 10858904006058 ()
  • 00858904006051 ()
DMD-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 AMPHETAMINE (AMP)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020018
In Commercial Distribution

  • 10858904006010 ()
  • 00858904006013 ()
DAM-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Respiratory Panel DFA Kit
EMD Millipore Corporation
3110
Not in Commercial Distribution

  • 04053252362064 ()
3110

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph
NEUROFAX ACQUISITION, PANEL PC
NIHON KOHDEN AMERICA, INC.
EEG-1250A
In Commercial Distribution

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph
EMG USB Control Panel
NATUS NEUROLOGY INCORPORATED
515-016700
In Commercial Distribution

  • 00382830041560 ()


  • Electromyograph
Viking Control Panel - German
NATUS NEUROLOGY INCORPORATED
842-129700
In Commercial Distribution

  • 00382830034500 ()


  • Electromyograph
Viking Control Panel - French
NATUS NEUROLOGY INCORPORATED
842-129800
In Commercial Distribution

  • 00382830034494 ()


  • Electromyograph
Viking EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689400
In Commercial Distribution

  • 00382830033893 ()


  • Electromyograph
Synergy EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689500
In Commercial Distribution

  • 00382830033879 ()


  • Electromyograph
PATCH PANEL FOR 80247
PENTAX OF AMERICA, INC.
80259
In Commercial Distribution

  • 04961333241163 ()


  • Transportable medical equipment stand, non-powered
SPINOMED ANTERIOR PANEL SET
MEDI MANUFACTURING, INC.
RKIT9201
In Commercial Distribution

  • 00636257095850 ()


  • Lumbar spine orthosis
Ready-Heat 6 Panel Blanket
TECHTRADE, LLC
S6RHLG
In Commercial Distribution

  • 00850017905122 ()
  • 00850017905023 ()


  • Hot/cold therapy pack, single-use
  • Bed blanket, single-use
MMR IHC Panel Antibody
Ventana Medical Systems, Inc.
790-5091
In Commercial Distribution

  • 07613336100561 ()
07862237001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MLH1 protein IVD, antibody
CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator
Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
CardioChek Lipid Panel Test
HENRY SCHEIN, INC.
5700414
In Commercial Distribution

  • 10304040037741 ()
  • 00304040037744 ()
5700414

  • Multiple lipid analyte IVD, kit, spectrophotometry
Assayed Respiratory Control Panel
MICROBIOLOGICS INC.
8199 Cepheid Xpert® Respiratory Control Panel
In Commercial Distribution

  • 70845357041240 ()
8199

  • Multiple-genus respiratory virus nucleic acid IVD, control
DISPOSABLE ZIP-TOP X-RAY PANEL/
Techno-Aide, Inc.
CCZ-14
In Commercial Distribution

  • G242CCZ1491 ()
  • G242CCZ149 ()
CCZ-14

  • Medical equipment/instrument drape, single-use
KIT, PANEL, PL691, 5-PCS
Securitas Healthcare LLC
RP131K
In Commercial Distribution

  • 00812664024137 ()
  • 00812664023710 ()
RP131K

  • Nurse call system alarm
THL Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN262
In Commercial Distribution

  • 00817100020339 ()


  • Diagnostic x-ray digital imaging conversion system
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ANNUNCIATOR,REMOTE PANEL,PC6K
Crest Healthcare Supply
18B600R
In Commercial Distribution

  • B48418B600R0 ()


  • Nurse call system
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-154
In Commercial Distribution

  • 20816490022729 ()
  • 10816490022722 ()
  • 00816490022725 ()
HCDOAA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-155
In Commercial Distribution

  • 20816490022248 ()
  • 10816490022241 ()
  • 00816490022244 ()
HCDOAA-155

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PSYCH PANEL LEVEL 1
UTAK LABORATORIES, INC.
PSYCH 1 F M ACL
In Commercial Distribution

  • B800PSYCH1FMACL5 ()
  • B800PSYCH1FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 1 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PANEL POSITIVE 2
UTAK LABORATORIES, INC.
FENT+ POS2 U KP
In Commercial Distribution

  • B800FENTPOS2UKP5 ()
  • B800FENTPOS2UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS2 U KP

  • Multiple drugs of abuse IVD, control
FENTANYL PANEL POSITIVE 1
UTAK LABORATORIES, INC.
FENT+ POS1 U KP
In Commercial Distribution

  • B800FENTPOS1UKP5 ()
  • B800FENTPOS1UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS1 U KP

  • Multiple drugs of abuse IVD, control
URINE BROAD PANEL MID
UTAK LABORATORIES, INC.
UBP M F DU
In Commercial Distribution

  • B800UBPMFDU5 ()
  • B800UBPMFDU0 ()

  • Total Volume: 1 Milliliter
UBP M F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL LOW
UTAK LABORATORIES, INC.
UBP L F DU
In Commercial Distribution

  • B800UBPLFDU5 ()
  • B800UBPLFDU0 ()

  • Total Volume: 1 Milliliter
UBP L F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL HIGH
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B800UBPHFVDU5 ()
  • B800UBPHFVDU0 ()

  • Total Volume: 1 Milliliter
UBP H F V DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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