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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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PROFILE-II ER® - 00690286000780

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601684
In Commercial Distribution

  • 00690286000780 ()
  • 10690286000787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

PROFILE®-V MEDTOXScan® - 00690286000049

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604022
In Commercial Distribution

  • 00690286000049 ()
  • 10690286000046 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

xTAG® Cystic Fibrosis Mutation Detection Kit - 00840487100455

The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution

  • 00840487100455 ()
I006C0068

  • Cystic fibrosis IVD, kit, multiplex

ProMax Surgical Gown - 00634916819045

ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Size 2XL
STANDARD TEXTILE CO., INC.
75615073
In Commercial Distribution

  • 10634916819042 ()
  • 00634916819045 ()


  • Surgical gown, reusable

Blue Diamond - 15060797552139

Blue Diamond® Patient Restraint Strap, extra long, is traditional rubber patient restraint with 2 airplane style buckles. It has a large mid panel that is protected by a removable Blue Diamond gel pad.
David Scott Company
BD2620XL
In Commercial Distribution

  • 15060797552139 ()

  • Width: 5 Inch
  • Length: 132 Inch
  • Height: .375 Inch
BD2620XL

  • Operating table patient pressure distribution pad, reusable

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control

Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 960 Wells - 00816870021874

No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021874 ()

  • Width: 7.75 Inch
7025-300E

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)

Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 480 Wells - 00816870021867

No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021867 ()

  • Width: 7.75 Inch
7025-300D

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)

Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 192 Wells - 00816870021850

No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021850 ()

  • Width: 7.75 Inch
7025-300B

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)

Free T3, Free T4, TSH Thyroid Panel AccuLite VAST CLIA Test System - 960 Wells - 00816870023311

No Description
MONOBIND, INC.
7075-300
In Commercial Distribution

  • 00816870023311 ()

  • Width: 7.75 Inch
7075-300E

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Free T3, Free T4, TSH Thyroid Panel AccuLite VAST CLIA Test System - 192 Wells - 00816870023298

No Description
MONOBIND, INC.
7075-300
In Commercial Distribution

  • 00816870023298 ()

  • Width: 7.75 Inch
7075-300B

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

PROFILE-II ER® - 00690286000292

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4 Methylenedioxymethamphetamine (MDMA) drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601672
In Commercial Distribution

  • 10690286000299 ()
  • 00690286000292 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Trans-Former - 00860001700121

Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
Reina Imaging
[T][#]-[Z]
In Commercial Distribution

  • 00860001700121 ()
Digital Detector Holder

  • X-ray film cassette holder

PRC Look™ - 00858526006736

The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1.1
In Commercial Distribution

  • 00858526006736 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer

PRC Look™ - 00858526006699

The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1
In Commercial Distribution

  • 00858526006699 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer

MicroScan - 15099590765385

Neg Urine Combo 103
Beckman Coulter, Inc.
C89645
In Commercial Distribution

  • 05099590753859 ()
  • 15099590765385 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590765378

Neg Urine Combo 102
Beckman Coulter, Inc.
C89644
In Commercial Distribution

  • 05099590753842 ()
  • 15099590765378 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590765361

Neg Urine Combo 101
Beckman Coulter, Inc.
C89643
In Commercial Distribution

  • 05099590753835 ()
  • 15099590765361 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590733919

Neg Urine Combo 90
Beckman Coulter, Inc.
C48640
In Commercial Distribution

  • 15099590733919 ()
  • 05099590731239 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590733902

Neg Urine Combo 89
Beckman Coulter, Inc.
C48639
In Commercial Distribution

  • 15099590733902 ()
  • 05099590731222 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704117

Neg Urine Combo 88
Beckman Coulter, Inc.
B1017-438
Not in Commercial Distribution

  • 15099590704117 ()
  • 05099590704110 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704100

Neg Urine Combo 87
Beckman Coulter, Inc.
B1017-437
Not in Commercial Distribution

  • 15099590704100 ()
  • 05099590704103 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704094

Neg Urine Combo 86
Beckman Coulter, Inc.
B1017-436
In Commercial Distribution

  • 15099590704094 ()
  • 05099590704097 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704087

Neg Urine Combo 85
Beckman Coulter, Inc.
B1017-435
In Commercial Distribution

  • 15099590704087 ()
  • 05099590704080 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704070

Neg Urine Combo 84
Beckman Coulter, Inc.
B1017-434
In Commercial Distribution

  • 15099590704070 ()
  • 05099590704073 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704032

Pos Combo 46
Beckman Coulter, Inc.
B1017-220
In Commercial Distribution

  • 15099590704032 ()
  • 05099590704035 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan - 15099590704025

Pos Combo 45
Beckman Coulter, Inc.
B1017-219
In Commercial Distribution

  • 15099590704025 ()
  • 05099590704028 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD

PROFILE-II ER® - 00690286000315

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601674
In Commercial Distribution

  • 00690286000315 ()
  • 10690286000312 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

xTAG® Cystic Fibrosis (CFTR) 60 kit v2 - 00840487100479

The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I024C0181
In Commercial Distribution

  • 00840487100479 ()
I024C0181

  • Cystic fibrosis IVD, kit, multiplex

xTAG® Cystic Fibrosis (CFTR) 39 kit v2 - 00840487100141

The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I027C0231
In Commercial Distribution

  • 00840487100141 ()
I027C0231

  • Cystic fibrosis IVD, kit, multiplex

ComPel Surgical Gown - 00634916691658

ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl Green ComPel I Sleeves, Comfort Panel Back Panels with Carbon, Color Coded ComPel Neck Binding, Tape Tie Closures at Neck and Waist, QCM, Size Large
STANDARD TEXTILE CO., INC.
75614305
In Commercial Distribution

  • 00634916691658 ()
  • 10634916691655 ()
75614305

  • Surgical gown, reusable

Acuitas - 10812125010041

Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
Opgen, Inc.
CP3233
Not in Commercial Distribution

  • 10812125010041 ()
CP3233

  • PCR/NAT negative control IVD

Identify® Diagnostics Drug Test Cups - 10850013035219

Identify Diagnostics Drug Test Cups CLIA WAIVED For In Vitro Diagnostics Use Only 12 Panel Configuration AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, PCP25, OXY100, THC50 Contents: Test Cups - 2, PI - 1, Security Seals - 2
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-BUP-AZ2
In Commercial Distribution

  • 00850013035212 ()
  • 10850013035219 ()
  • 20850013035216 ()
ID-CP12-BUP-AZ2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identify Health - 10850013035189

Identify Health 14 Panel CLIA Waived Cup with 6 Adulterations- AMP500, BAR300, BUP10, BZO300, COC150, EDDP300, MDMA500, MET500, MTD300, OPI300, OXY100, PCP25, TCA1000, THC50 - (SG, pH, OX) x (CR, NI, GL) Approx. 3.0mm Strips 25 tests/box
MEDICAL DISTRIBUTION GROUP INC
ID-H14-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035182 ()
  • 10850013035189 ()
ID-H14-ADULT-1-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Acuitas - 00812125010044

Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
Opgen, Inc.
CP3233
Not in Commercial Distribution

  • 00812125010044 ()
CP3233

  • PCR/NAT negative control IVD

Nubway - 06971679500624

The semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.
Beijing Nubway S&T Co., Ltd.
QDTM-02
In Commercial Distribution

  • 06971679500624 ()


  • Dermatological diode laser system

Senographe Pristina - 00840682118460

No Description
GE MEDICAL SYSTEMS
EKB1
In Commercial Distribution

  • 00840682118460 ()


  • Stationary mammographic x-ray system, digital

not applicable - 00840682122603

No Description
GE MEDICAL SYSTEMS
5727669
In Commercial Distribution

  • 00840682122603 ()


  • Stationary mammographic x-ray system, digital

Rapid Response - 00722066000847

Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1P29-25
In Commercial Distribution

  • 00722066000847 ()
  • 00722066004029 ()
D10.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Welch Allyn, Inc. - 00732094066524

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066524 ()
77792-MNOBP

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094067699

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094067699 ()
76797-X

  • Basic power supply, reusable

Blue Diamond - 15060797552313

Double Bariatric Pateient Restraint Strap for bariatric patients. Padded mid panel to help protect patient from pressure and sheer injury. Dual extra durable securing straps with airplane style buckles to adjust strap length . Extremely durable and easily cleaned
David Scott Company
BD8000
In Commercial Distribution

  • 15060797552313 ()

  • Width: 12 Inch
  • Length: 80 Inch
BD8000

  • Medical table restraint anchor

Warrior Lite Blood and Fluid Warmer Base Unit - 07290016740103

QinFlow Warrior Lite Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a LED panel display for user notifications.
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 07290016740103 ()
QIF03-BUA1000

  • Conduction blood/fluid warmer

Status Toxi Cup - 00868348000256

Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG
Lifesign L.L.C.
65C13+4
In Commercial Distribution

  • 10868348000253 ()
  • 00868348000256 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical

Planmeca Compact - 06430035420575

Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change.
Planmeca Oy
i5
In Commercial Distribution

  • 06430035420575 ()
30013450, 30015629, 30015630, 30015632, 30015633

  • Dental delivery system

STEPHANIX - 03664049000017

D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections. Not for mammography.
STEPHANIX
D2RS
In Commercial Distribution

  • 03664049000017 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

Automatic Radiographic Film Processor - 08809413810181

New retractable feed tray provides space savings for small dark rooms. Exceptionally quiet operation. 1. Microprocessor controlled. 2. High-quality film image 3. The control panel digitally displays. 4. Water level sensor prevents overflowing of tank. 5. Stand-by mode for energy saving.
JPI HEALTHCARE. CO., LTD.
JP-33
In Commercial Distribution

  • 08809413810181 ()


  • Darkroom automated x-ray film processor

STEPHANIX - 03664049000024

The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. Not for mammography
STEPHANIX
D2RS_AT
In Commercial Distribution

  • 03664049000024 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

Panther Fusion® - 15420045509221

Panther Fusion® Internal Control-S.
Hologic, Inc.
KIT, INTERNAL CONTROL -S, FUSION, IVD
In Commercial Distribution

  • 15420045509221 ()
PRD-04332

  • Exogenous DNA/RNA internal control IVD, kit

Welch Allyn, Inc. - 00732094136692

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (# 11720), Pneumatic Otoscope (#20201), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094136692 ()
77798

  • Aneroid manual sphygmomanometer
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