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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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U-Screen - 00858998006074

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-10MOB-300
Not in Commercial Distribution

  • 00858998006074 ()
USSCupA-10MOB-300

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

U-Screen - 00858998006067

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Tech Subsidiary Acquisition
USSCupA-10M
Not in Commercial Distribution

  • 00858998006067 ()
USSCupA-10M

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

Alere iCup Dx Pro 2 - 00858945006812

iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
Instant Technologies, Inc.
I-DXP-167-02
In Commercial Distribution

  • 00858945006812 ()
I-DXP-167-02

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

HarmonyAIR - 00724995199173

The G5 Dual Light with Single Flat Panel Monitor, HD Camera Ready, Connect Point and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995199173 ()
LGH51CPT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995192280

The G5 Single Light with Single Flat Panel Monitor Mount, High Density Camera Ready with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192280 ()
LGH08T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191740

The M5/M7 Dual Package with Single High Density Flat Panel Monitor Mount, without/Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191740 ()
LM08T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995191733

The M5/M7 Dual Package with Single High Density Flat Panel Monitor Mount, without Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191733 ()
LM08

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995192464

The G5 Dual Light with Dual Single Flat Panel Monitor, High Density Camera Ready with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995192464 ()
LGH51T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995192419

The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready, Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192419 ()
LGH42

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995192402

The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192402 ()
LGH12T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995192020

The G5 Single Light with Single Flat Panel Monitor Mount, Non Camera, Single Cardanic and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192020 ()
LG37T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995200183

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, No Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200183 ()
LAH04INNDTA

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995200176

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200176 ()
LAH04IN02TA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995200169

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200169 ()
LAH04IN01TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995200152

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200152 ()
LAH04NCNDA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995200145

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200145 ()
LAH04NC02A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995200138

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200138 ()
LAH04NC01A

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995199944

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199944 ()
LAH24INNDTA

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995199937

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199937 ()
LAH24IN02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199920

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199920 ()
LAH24IN01TA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199913

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199913 ()
LAH24NCNDA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199906

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199906 ()
LAH24NC02A

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995199890

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199890 ()
LAH24NC01A

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199494

The A-Series High Definition Dual Light, Single Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199494 ()
LAH02NCNDTA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199487

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199487 ()
LAH02NC02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199470

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199470 ()
LAH02NC01TA

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

Identify®Diagnostics Drug Test Cards - 10850721007775

Identify®Diagnostics Drug Test Cards 7 Panel Drug Test Card BUP/BZO/COC/MET/MOP/OXY/THC with Adulteration strip (OX/CRE/pH)
MEDICAL DISTRIBUTION GROUP INC
ID-CP7-DIP-ADULT-AZ10
In Commercial Distribution

  • 20850721007772 ()
  • 10850721007775 ()
  • 00850721007778 ()
ID-CP7-DIP-ADULT-AZ10

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

Identify®Diagnostics Drug Test Cards - 10850721007768

Identify®Diagnostics Drug Test Cards 7 Panel Drug Test Card BUP/BZO/COC/MET/MOP/OXY/THC with Adulteration strip (OX/CRE/pH)
MEDICAL DISTRIBUTION GROUP INC
ID-CP7-DIP-ADULT-AZ5
In Commercial Distribution

  • 20850721007765 ()
  • 10850721007768 ()
  • 00850721007761 ()
ID-CP7-DIP-ADULT-AZ5

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

Identify Diagnostics USA - 10850013035158

dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100 25 Test/Box
MEDICAL DISTRIBUTION GROUP INC
ID-US8-1
In Commercial Distribution

  • 00850013035151 ()
  • 10850013035158 ()
ID-US8-1-AZ25

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

UCP Home Drug Screening Test Cups - 10817038021788

UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-8124-RCN
In Commercial Distribution

  • 20817038021785 ()
  • 10817038021788 ()
  • 00817038021781 ()
U-CUP-8124-RCN

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

UCP Home Drug Screening Test Cups - 10817038021634

UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-9124-RCN
In Commercial Distribution

  • 20817038021631 ()
  • 10817038021634 ()
  • 00817038021637 ()
U-CUP-9124-RCN

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

UCP Home Drug Screening Test Cups - 10817038021603

UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-3124-RCN
In Commercial Distribution

  • 20817038021600 ()
  • 10817038021603 ()
  • 00817038021606 ()
U-CUP-3124-RCN

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

UCP Home Drug Screening Test Cups - 10817038021597

UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-8124-RCN
In Commercial Distribution

  • 20817038021594 ()
  • 10817038021597 ()
  • 00817038021590 ()
U-CUP-8124-RCN

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

DrugCheck Waive - B298DCC8120550

DrugCheck Waive 12 Panel Cup Test, (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) With Cr, Ni, pH, Bl, S.G.
EXPRESS DIAGNOSTICS INT'L, INC.
DCC-81205-5
Not in Commercial Distribution

  • B298DCC8120550 ()
DCC-81205-5

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

DrugCheck Waive - B298DC8121050

DrugCheck Waive 12 Panel Cup Test, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G
EXPRESS DIAGNOSTICS INT'L, INC.
DC 81210-5
Not in Commercial Distribution

  • B298DC8121050 ()
DC 81210-5

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

Alere iCup Dx Pro 2 - 00817405020362

iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
Instant Technologies, Inc.
I-DXP-167-02
In Commercial Distribution

  • 00817405020362 ()
I-DXP-167-02

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

iScreen™ - 00817405023431

14 PANEL CLIA WAIVED ROUND CUP AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,PPX,TCA,THC SVT (Cr, ph, S.G.)
Instant Technologies, Inc.
ABTDUAW114702B
In Commercial Distribution

  • 30817405023432 ()
  • 00817405023431 ()
  • 10817405023438 ()
ABTDUAW114702B

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

Overhead Tube Crane - 00817100020094

NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5200
In Commercial Distribution

  • 00817100020094 ()


  • Stationary basic diagnostic x-ray system, digital

Generic - 00812203030728

11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712K03A-G
In Commercial Distribution

  • 00812203030728 ()


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

STATCUP® - 00816036026637

STATCUP 12 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MDMA/MOP/MTD/OXY/PCP/PPX/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-51127-0-A
In Commercial Distribution

  • 00816036027139 ()
  • 00816036026637 ()
SCP-51127-0-A

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

ImmuTest Drugs of Abuse Cup - 00816565020298

12 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-12BUP
Not in Commercial Distribution

  • 00816565020298 ()
IMCA-12BUP

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

ImmuTest Drugs of Abuse Cup - 00816565020342

9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests (for Impact Employees)
AMEDITECH INC.
IMCA-9CM5-5
Not in Commercial Distribution

  • 00816565020342 ()
IMCA-9CM5-5

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

UScreen® - 00817405021246

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCupA-10M
In Commercial Distribution

USSCupA-10M

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

ESTEEM+ - 00768455115358

Esteem®+ One-Piece Drainable Extended Wear Cut-To-Fit Pouch W/ Invisiclose®, Durahesive Plus, Filter, One-Sided Comfort Panel, 12" Clear, 2 1/2 In (64Mm)
CONVATEC, PURCHASING DEPARTMENT
416976
In Commercial Distribution

  • 10768455115355 ()
  • 00768455115358 ()
  • 00768455189045 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455115334

Esteem®+ One-Piece Drainable Extended Wear Cut-To-Fit Pouch W/ Invisiclose®, Durahesive Plus, Filter, One-Sided Comfort Panel, 12" Opaque, 2 1/2 In (64Mm)
CONVATEC, PURCHASING DEPARTMENT
416975
In Commercial Distribution

  • 10768455115331 ()
  • 00768455115334 ()
  • 00768455189038 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455106660

Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap,W/1 Sided Comfort Panel, Trans, 1 1/2" (38 Mm)
CONVATEC, PURCHASING DEPARTMENT
650833
In Commercial Distribution

  • 10768455106667 ()
  • 00768455106660 ()
  • 00768455190270 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455106653

Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1 1/4" (32 Mm)
CONVATEC, PURCHASING DEPARTMENT
650832
In Commercial Distribution

  • 10768455106650 ()
  • 00768455106653 ()
  • 00768455190263 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455106646

Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1 1/8" (28 Mm.)
CONVATEC, PURCHASING DEPARTMENT
650831
In Commercial Distribution

  • 10768455106643 ()
  • 00768455106646 ()
  • 00768455190256 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455106134

ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Transparent, 2 in. (50 mm)
CONVATEC, PURCHASING DEPARTMENT
413152
Not in Commercial Distribution

  • 10768455106131 ()
  • 00768455106134 ()
  • 80768455106130 ()


  • One-piece intestinal ostomy bag, closed-ended

ACTIVELIFE - 00768455106097

ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Transparent, 1 in. (25 mm)
CONVATEC, PURCHASING DEPARTMENT
413148
Not in Commercial Distribution

  • 10768455106094 ()
  • 00768455106097 ()
  • 80768455106093 ()


  • One-piece intestinal ostomy bag, closed-ended
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