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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Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PS-DOA-654
In Commercial Distribution

  • 00850557007324 ()
  • 00850557007331 ()
  • 10850557007338 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-254
In Commercial Distribution

  • 00850557007140 ()
  • 00850557007157 ()
  • 10850557007154 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: COC|AMP|MAMP|THC|OPI
MERGERS MARKETING, INC.
PSC-DOA-254M
In Commercial Distribution

  • 20851000007162 ()
  • 10851000007165 ()
  • 00851000007168 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196991 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196953 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860113002083 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution

  • 00860004081661 ()
  • 00860004081654 ()
  • 00860004081647 ()
P33-10-MET

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Tech Subsidiary Acquisition
USSCup-5M
Not in Commercial Distribution

  • 00858998006036 ()
USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-12-BUP
In Commercial Distribution

  • 00858984006316 ()
NCard-12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-09-01
In Commercial Distribution

  • 00858984006309 ()
NCard-09-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The A-Series Spindle Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190309 ()
LAS000007

  • Medical monitor/light mount
Reusable non-sterile foot panel for use with Calypso 4D Localization System and Varian Exact base
MEDTEC, INC.
20IL430035
Not in Commercial Distribution

  • 00841439102107 ()

  • Length: 120 Centimeter
20IL430035

  • Indexed-immobilization patient positioning system
Reusable non-sterile head panel for use with Calypso 4D Localization System and Varian Exact base
MEDTEC, INC.
20IL430030
Not in Commercial Distribution

  • 00841439102084 ()

  • Length: 56 Centimeter
20IL430030

  • Indexed-immobilization patient positioning system
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-9104
In Commercial Distribution

  • 20817038021341 ()
  • 10817038021344 ()
  • 00817038021347 ()
U-CUP-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-8104
In Commercial Distribution

  • 20817038021129 ()
  • 10817038021122 ()
  • 00817038021125 ()
U-CUP-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Cup (10.46) -OXY100 MDMA500 COC150 BZO300 MTD300 BUP10 MET500 MOR300 AMP500 THC50
BTNX Inc
D10.46-1VF
In Commercial Distribution

  • 00722066009017 ()
  • 10722066009014 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/OXY
CONFIRM BIOSCIENCES, INC.
CB-HE-4104
In Commercial Distribution

  • 00895330002783 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Card - CLIA COC,THC,OPI,BZO,mAMP,TCA,OXY,BUP,BAR,MTD
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 9 Panel Dip Card - AMP1000/BAR300/BZO300/COC300/mAMP1000/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-194
In Commercial Distribution

  • 00895330002608 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Phototherapy Unit. UVB Narrowband. Single upright panel with 8 lamps. Mounts to wall or stand.
Medtek Lighting Corporation
80B
In Commercial Distribution

  • B343B80 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 170 Pound
80B

  • Ultraviolet phototherapy unit, professional
Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall.
Medtek Lighting Corporation
20B
In Commercial Distribution

  • B343B20 ()

  • Area/Surface Area: 621 Square inch
  • Weight: 40 Pound
20B

  • Ultraviolet phototherapy unit, professional
CRL STAT 9 panel Cup - KCUR920077 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920077
In Commercial Distribution

  • 00817815021010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 25 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-25BX
In Commercial Distribution

  • 10816862026136 ()
  • 00816862026139 ()
  • 00816862026122 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-10BX
In Commercial Distribution

  • 10816862026112 ()
  • 00816862026115 ()
  • 00816862026108 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 5 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-5BX
In Commercial Distribution

  • 10816862026099 ()
  • 00816862026092 ()
  • 00816862026085 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
8 Panel E&I Oral Click Cube AMP50, BAR50, COC20, MDMA50, MET50, MTD30, OPI40, OXY20
Instant Technologies, Inc.
ABTOFCUBE0801A
In Commercial Distribution

  • 30817405023920 ()
  • 00817405023929 ()
  • 10817405023926 ()
ABTOFCUBE0801A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10
Instant Technologies, Inc.
ABTOFCUBE0901A
In Commercial Distribution

  • 30817405023562 ()
  • 00817405023561 ()
  • 10817405023568 ()
ABTOFCUBE0901A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification 2 (BCID2) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5258P
Not in Commercial Distribution

  • 70845357043282 ()
5258P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8235
In Commercial Distribution

  • 70845357043084 ()
8235

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8234
In Commercial Distribution

  • 70845357043077 ()
8234

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8206
In Commercial Distribution

  • 70845357042810 ()
8206

  • Multiple Mycobacterium species nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory Pathogens (16 Strains) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8198
Not in Commercial Distribution

  • 70845357041455 ()
8198

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8203
In Commercial Distribution

  • 70845357041387 ()
8203

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control
12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test Strips CRE/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-5125A3A
In Commercial Distribution

  • 20816490021753 ()
  • 10816490021756 ()
  • 00816490021759 ()
HCDOAV-5125A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
Healgen Scientific Limited Liability Company
HCDOAF-5114A6
In Commercial Distribution

  • 20816490021692 ()
  • 10816490021695 ()
  • 00816490021698 ()
HCDOAF-5114A6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
Healgen Scientific Limited Liability Company
HCDOAF-664A6
In Commercial Distribution

  • 20816490021685 ()
  • 10816490021688 ()
  • 00816490021681 ()
HCDOAF-664A6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-2167-0
In Commercial Distribution

  • 00816036026583 ()
  • 00816036027085 ()
SCP-2167-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP
MICRO DISTRIBUTING, L.C
STATII-0257-0
In Commercial Distribution

  • 00816036025364 ()
  • 00816036025371 ()
STATII-0257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-3P
Not in Commercial Distribution

  • 00816565020199 ()
IMCA-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. IDTC- 5 Panel Drug Test Cup (COC,mAMP,OPI300, OXY, MTD)-(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-5-60579
In Commercial Distribution

  • 00816610020846 ()
CLIA-IDTC-5-60579

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
X-MIND trium PAN version including one PAN sensor, with control panel on the left side
DE GÖTZEN SRL
XMT PAN L
Not in Commercial Distribution

  • D804W09000070 ()
W0900007

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN version including one PAN sensor,with control panel on the right side
DE GÖTZEN SRL
XMT PAN R
Not in Commercial Distribution

  • D804W09000010 ()
W0900001

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240)
Quest Diagnostics
DOA-154-181
In Commercial Distribution

  • 00869419000243 ()
  • 20869419000247 ()
DOA-154-ONC62B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
420697
In Commercial Distribution

  • 10768455127600 ()
  • 00768455127603 ()
  • 00768455189564 ()


  • Multiple-piece intestinal ostomy bag, open-ended
Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
420696
In Commercial Distribution

  • 10768455127594 ()
  • 00768455127597 ()
  • 00768455189557 ()


  • Multiple-piece intestinal ostomy bag, open-ended
Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
420695
In Commercial Distribution

  • 10768455127587 ()
  • 00768455127580 ()
  • 00768455189540 ()


  • Multiple-piece intestinal ostomy bag, open-ended
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