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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Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.39-2FC1E)- AMP50, COC20, MET50, OPI40, PCP10. For employment and insurance testing.
BTNX Inc
D5.39-2FC1E
In Commercial Distribution

  • 00722066006771 ()
  • 10722066006778 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.2-2FC1E)- TAMP50, COC20, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D5.2-2FC1E
In Commercial Distribution

  • 00722066006764 ()
  • 10722066006761 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.1.1-2FC1E)-THC40 COC20 AMP50 MET50 OPI40. For employment and insurance testing.
BTNX Inc
D5.1.1-2FC1E
In Commercial Distribution

  • 10722066006617 ()
  • 00722066006610 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Cup - KCUR920092 AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/OPI300/OXY100/PCP25/THC50 (SG/CR/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920092
In Commercial Distribution

  • 00817815021171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920083 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920083
In Commercial Distribution

  • 00817815021119 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50(OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920126
In Commercial Distribution

  • 00817815020655 ()
  • 00817815020662 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<COC>+<AMP>+(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP)
Instant Technologies, Inc.
DUE-197-341
In Commercial Distribution

  • 10817405024077 ()
  • 00817405024070 ()
DUE-197-341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Panel Urine Test (10 Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC), 25T/Box
WONDFO USA CO., LTD.
DWDOA-3104-25BX-A
In Commercial Distribution

  • 10816862024026 ()
  • 00816862024029 ()
  • 00816862024036 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2397-0-A
In Commercial Distribution

  • 00816036025494 ()
  • 00816036025487 ()
SCP-2397-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/ + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STAII-03107-0-A
In Commercial Distribution

  • 00816036025463 ()
  • 00816036025456 ()
STAII-03107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH, OX, CR.
MICRO DISTRIBUTING, L.C
STATII-4267-0-A
In Commercial Distribution

  • 00816036025401 ()
  • 00816036025418 ()
STATII-4267-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0-A
In Commercial Distribution

  • 00816036025111 ()
  • 00816036025272 ()
STATⅡ-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-12107-0-A
In Commercial Distribution

  • 00816036025081 ()
  • 00816036025241 ()
STATⅡ-12107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127
In Commercial Distribution

  • 00816036021687 ()
  • 00816036021694 ()
FST-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-7MT-W
Not in Commercial Distribution

  • 00816565020243 ()
IMCA-7MT-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 10-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1790UVB-NB
In Commercial Distribution

  • B2191790UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1780UVB-NB
In Commercial Distribution

  • B2191780UVBNB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1760UVB-NB
In Commercial Distribution

  • B2191760UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1740UVB-NB
In Commercial Distribution

  • B2191740UVBNB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-BROADBAND Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1760UVB
In Commercial Distribution

  • B2191760UVB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-BROADBAND Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1740UVB
In Commercial Distribution

  • B2191740UVB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Fastep 12 Panel Urine Drug Test Cup (AMP, BAR, BUP, BZO, COC, MET, MDMA, MOP,MTD, OXY, PCP, THC) – 4 pack
Azure Biotech, Inc.
AZC-6125
In Commercial Distribution

  • 00810022630396 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/2" (38Mm)
CONVATEC, PURCHASING DEPARTMENT
416751
In Commercial Distribution

  • 10768455112217 ()
  • 00768455112210 ()
  • 00768455188604 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/2" (38Mm)
CONVATEC, PURCHASING DEPARTMENT
416750
In Commercial Distribution

  • 10768455112200 ()
  • 00768455112203 ()
  • 00768455188598 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416749
In Commercial Distribution

  • 10768455112194 ()
  • 00768455112197 ()
  • 00768455188581 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416748
In Commercial Distribution

  • 10768455112187 ()
  • 00768455112180 ()
  • 00768455188574 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/4" (32Mm)
CONVATEC, PURCHASING DEPARTMENT
416747
In Commercial Distribution

  • 10768455112170 ()
  • 00768455112173 ()
  • 00768455188567 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/4" (32Mm)
CONVATEC, PURCHASING DEPARTMENT
416746
In Commercial Distribution

  • 10768455112163 ()
  • 00768455112166 ()
  • 00768455188550 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/8" (28Mm)
CONVATEC, PURCHASING DEPARTMENT
416745
In Commercial Distribution

  • 10768455112156 ()
  • 00768455112159 ()
  • 00768455188543 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/8" (28Mm)
CONVATEC, PURCHASING DEPARTMENT
416744
In Commercial Distribution

  • 10768455112149 ()
  • 00768455112142 ()
  • 00768455188536 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 9/16" (40Mm)
CONVATEC, PURCHASING DEPARTMENT
416737
In Commercial Distribution

  • 10768455112071 ()
  • 00768455112074 ()
  • 00768455188468 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 9/16" (40Mm)
CONVATEC, PURCHASING DEPARTMENT
416736
In Commercial Distribution

  • 10768455112064 ()
  • 00768455112067 ()
  • 00768455188451 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416733
In Commercial Distribution

  • 10768455112033 ()
  • 00768455112036 ()
  • 00768455188437 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416732
In Commercial Distribution

  • 10768455112026 ()
  • 00768455112029 ()
  • 00768455188420 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416729
In Commercial Distribution

  • 10768455111999 ()
  • 00768455111992 ()
  • 00768455188413 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416728
In Commercial Distribution

  • 10768455111982 ()
  • 00768455111985 ()
  • 00768455188406 ()


  • One-piece intestinal ostomy bag, open-ended
ActiveLife One-Piece Cut-to-Fit Closed-End Pouch with Skin Barrier and Filter, with 1 Sided Comfort Panel, Opaque, 3/4 in. (19 mm)
CONVATEC, PURCHASING DEPARTMENT
413141
Not in Commercial Distribution

  • 10768455106025 ()
  • 00768455106028 ()
  • 80768455106024 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175768
Not in Commercial Distribution

  • 10768455102430 ()
  • 00768455102433 ()
  • 80768455102439 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175761
Not in Commercial Distribution

  • 10768455102379 ()
  • 00768455102372 ()
  • 80768455102378 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125343
In Commercial Distribution

  • 10768455102041 ()
  • 00768455102044 ()
  • 00768455180578 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25Mm.)
CONVATEC, PURCHASING DEPARTMENT
125339
In Commercial Distribution

  • 10768455102003 ()
  • 00768455102006 ()
  • 00768455180530 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125336
In Commercial Distribution

  • 10768455101976 ()
  • 00768455101979 ()
  • 00768455180509 ()


  • One-piece intestinal ostomy bag, open-ended
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
No Description
VAREX IMAGING CORPORATION
Nexus DRF (RF/DR)
In Commercial Distribution

  • 00854344007078 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DRF (RF/DR)
Not in Commercial Distribution

  • 00858086006023 ()


  • X-ray system computer, diagnostic, general-purpose
The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.
LUMINEX CORPORATION
50-10020
Not in Commercial Distribution

  • 00840487100158 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
MESA BIOTECH, INC.
1028
In Commercial Distribution

  • B54010280 ()
1028

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Fourteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | EDDP | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC +AD
MERGERS MARKETING, INC.
PSC-DOA-2145AD
In Commercial Distribution

  • 00850557007805 ()
  • 00850557007812 ()
  • 10850557007819 ()


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