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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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HarmonyAIR - 00724995171025

The HarmonyAIR E-Series Spindle Single Light Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171025 ()
LES000004

  • Medical monitor/light mount

HarmonyAIR - 00724995171018

The HarmonyAIR E-Series Spindle Single Light Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171018 ()
LES000003

  • Medical monitor/light mount

HarmonyAIR - 00724995170998

The HarmonyAIR E-Series Spindle Dual Light Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170998 ()
LES000001

  • Medical monitor/light mount

HarmonyAIR - 00724995170677

The HarmonyAIR E-Series 59-inch Auxiliary Arm Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170677 ()
LES0071

  • Medical monitor/light mount

HarmonyAIR - 00724995170561

The HarmonyAIR E-Series Single Flat Panel Monitor Yoke with Handle is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170561 ()
LES0002

  • Medical monitor/light mount

Rapid Response - 00722066004678

One Step 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
BTNX Inc
D9.11-1V
In Commercial Distribution

  • 00722066004678 ()


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

Rapid Response - 00722066004593

10-Drug Test Panel - 25/kit(10.22) - COC300 AMP1000 MET1000 THC50 MTD300 MOP300 OXY100 BAR300 BZO300 BUP10
BTNX Inc
D10.22-1P29-25
In Commercial Distribution

  • 00722066004593 ()
  • 00722066004609 ()


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

HarmonyAIR - 00724995166656

The Dual Flat Panel Light Head Spindle-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166656 ()
10088696

  • Medical monitor/light mount

HarmonyAIR - 00724995165499

The M-Series Flat Panel Monitor Spring Arm Assembly is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165499 ()
LM0021

  • Medical monitor/light mount

Six Panel PreScreen Plus Dip Card (CLIA Waived) - 00851000007151

Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC|AMP|MET|THC|OPI|PCP
MERGERS MARKETING, INC.
PS-DOA-164
In Commercial Distribution

  • 20851000007155 ()
  • 10851000007158 ()
  • 00851000007151 ()


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

Five Panel PreScreen Plus Cup (CLIA Waived) With Alcohol - 00851000007045

Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC With Alcohol
MERGERS MARKETING, INC.
PSC-DOA-254A
In Commercial Distribution

  • 10851000007059 ()
  • 00851000007052 ()
  • 00851000007045 ()


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

Five Panel Clear Scan Drug Test Cup With Adulterants - 00850557007843

Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC With Adulterants
MERGERS MARKETING, INC.
CSC-254AD
In Commercial Distribution

  • 10850557007857 ()
  • 00850557007850 ()
  • 00850557007843 ()


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

Six Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007164

Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-264
In Commercial Distribution

  • 00850557007164 ()
  • 00850557007171 ()
  • 10850557007178 ()


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

Five Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007126

Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: COC | MDMA | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-1554
In Commercial Distribution

  • 10850557007130 ()
  • 00850557007133 ()
  • 00850557007126 ()


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

Five Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007102

Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-154
In Commercial Distribution

  • 00850557007102 ()
  • 00850557007119 ()
  • 10850557007116 ()


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

Six Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007287

Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-564
In Commercial Distribution

  • 10850557007291 ()
  • 00850557007294 ()
  • 00850557007287 ()


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

HarmonyAIR - 00724995170790

The HarmonyAIR E-Series 67-inch Auxiliary Arm Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170790 ()
LES0082

  • Medical monitor/light mount

HarmonyAIR - 00724995170769

The HarmonyAIR E-Series 67-inch Auxiliary Arm Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170769 ()
LES0079

  • Medical monitor/light mount

HarmonyAIR - 00724995170721

The HarmonyAIR E-Series 59-inch Auxiliary Arm Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170721 ()
LES0076

  • Medical monitor/light mount

Forest - D0692184BCG0

WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2184BC-G
In Commercial Distribution

  • D0692184BCG0 ()


  • Dental delivery system

Forest - D0692184BCC0

WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184BC-C
In Commercial Distribution

  • D0692184BCC0 ()


  • Dental delivery system

u-Card TM Drug Test Screen 7 panel Test Card - 10817038022013

u-Card TM Drug Test Screen 7 panel Test Card COC/AMP/MET/THC/OPI/BZO/OXY
UCP BIOSCIENCES, INC.
U-DOA-374L
In Commercial Distribution

  • 10817038022013 ()
  • 00817038022016 ()
  • 20817038022010 ()
U-DOA-374L

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

U-Cup TM Drug Test Screen - 10817038021948

U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET
UCP BIOSCIENCES, INC.
U-CUP-564
In Commercial Distribution

  • 20817038021945 ()
  • 10817038021948 ()
  • 00817038021941 ()
U-CUP-564

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

u-Card Drug Test Screen - 10817038021351

12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-6124L
In Commercial Distribution

  • 20817038021358 ()
  • 10817038021351 ()
  • 00817038021354 ()
U-DOA-6124L

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

u-Cup Drug Test Screen - 10817038021283

5 Panel Drug Test Cup AMP/COC/MET/OPI/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-254
In Commercial Distribution

  • 20817038021280 ()
  • 10817038021283 ()
  • 00817038021286 ()
U-DUD-254

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

Healgen (Private Label) - 7104 - 00895330002820

Healgen (DrugConfirm) - 10 Panel Dip Card - BAR300/BUP10/BZO300/COC300/mAMP1000/MTD300/MOP2000/OXY100/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002820 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine 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
  • Oxycodone IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 3104C - 00895330002769

Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3104
In Commercial Distribution

  • 00895330002769 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) FLATCUP-8104A3 - 00895330002745

10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104A3
In Commercial Distribution

  • 00895330002745 ()


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

Healgen (Private Label) - 8104C - 00895330002677

Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-8104
In Commercial Distribution

  • 00895330002677 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine 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
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Sterile Labels - 10849771052927

Sterile Labels - Custom TNHO0004, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL214
In Commercial Distribution

  • 20849771052924 ()
  • 10849771052927 ()
  • 00849771052920 ()
SL214

  • Procedural medication labelling set

Sterile Labels - 10849771052910

Sterile Labels - Custom FLHU009, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL213
In Commercial Distribution

  • 20849771052917 ()
  • 10849771052910 ()
  • 00849771052913 ()
SL213

  • Procedural medication labelling set

NA - 10849771050725

Sterile Labels - Sterile Labels -10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050723 ()
  • 10849771050725 ()
  • 00849771050728 ()
  • 00849771032922 ()
SL203

  • Procedural medication labelling set

Key Surgical Sterile Labels - 10849771040016

Sterile Labels - Custom MATR002, 10 labels per panel, 4 panels per pouch, 100 packages per box.
KEY SURGICAL, INC.
SL402
In Commercial Distribution

  • 20849771040013 ()
  • 10849771040016 ()
  • 00849771040019 ()
SL402

  • Procedural medication labelling set

Key Surgical Sterile Labels - 10849771040009

Sterile Labels - Custom INBL005, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL215
In Commercial Distribution

  • 20849771040006 ()
  • 10849771040009 ()
  • 00849771040002 ()
SL215

  • Procedural medication labelling set

reditest® - 10858904006430

PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

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

Identify® Diagnostics Drug Test Cards - 10850721007676

Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ25
In Commercial Distribution

  • 20850721007673 ()
  • 10850721007676 ()
  • 00850721007679 ()
ID-CP5-DIP-AZ25

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

Identify® Diagnostics Drug Test Cards - 10850721007614

Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ10
In Commercial Distribution

  • 20850721007611 ()
  • 10850721007614 ()
  • 00850721007617 ()
ID-CP5-DIP-AZ10

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

Identify® Diagnostics Drug Test Cards - 10850721007508

Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ5
In Commercial Distribution

  • 20850721007505 ()
  • 10850721007508 ()
  • 00850721007501 ()
ID-CP5-DIP-AZ5

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

UCP Home Drug Screening Test Cups - 10850721007058

10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-6104-RCN
In Commercial Distribution

  • 20850721007055 ()
  • 10850721007058 ()
  • 00850721007051 ()
U-CUP-6104-RCN

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

OEC - 00618125190812

OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector) Drape, Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31047
In Commercial Distribution

  • 10618125190826 ()
  • 00618125190812 ()
8849416

  • Medical equipment/instrument drape, single-use

Premier Biotech - 00812203030506

10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
CHEMTRON BIOTECH INC
PCA-10X3X-ALT
In Commercial Distribution

  • 00812203030506 ()


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

QC Sets and Panels: Helix Elite™ - 70845357044098

QC Sets and Panels: Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)
MICROBIOLOGICS INC.
8254
In Commercial Distribution

  • 70845357044098 ()
8254

  • Multiple-type bloodstream pathogen nucleic acid IVD, control

iScreen™ - 00817405024117

iScreen 10 Panel CLIA Click Cup AMP1000, BAR300, BZO300, COC300, MET1000, MDMA500, MOP300, MTD300, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW110701A
In Commercial Distribution

  • 30817405024118 ()
  • 00817405024117 ()
  • 10817405024114 ()
ABTDOAW110701A

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

iScreen™ - 00817405024032

9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10
Instant Technologies, Inc.
ABTOFCUBE0903C
In Commercial Distribution

  • 30817405024033 ()
  • 00817405024032 ()
  • 10817405024039 ()
ABTOFCUBE0903C

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

iScreen™ - 00817405023257

6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW16701A
In Commercial Distribution

  • 30817405023258 ()
  • 00817405023257 ()
  • 10817405023254 ()
ABTDUAW16701A

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

iScreen™ - 00817405023912

9 Panel E&I Oral Click Cube AMP50, BUP5, BZO10, COC20, MET50, MTD30, OPI40, OXY20, THC40
Instant Technologies, Inc.
ABTOFCUBE0902B
In Commercial Distribution

  • 30817405023913 ()
  • 00817405023912 ()
  • 10817405023919 ()
ABTOFCUBE0902B

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

iScreen™ - 00817405023578

10 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE1001A
In Commercial Distribution

  • 30817405023579 ()
  • 00817405023578 ()
  • 10817405023575 ()
ABTOFCUBE1001A

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

iScreen™ - 00817405023479

10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, PCP25, THC50
Instant Technologies, Inc.
ABTDOAK110701A
In Commercial Distribution

  • 30817405023470 ()
  • 00817405023479 ()
  • 10817405023476 ()
ABTDOAK110701A

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

iScreen™ - 00817405023462

10 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW110401A
In Commercial Distribution

  • 30817405023463 ()
  • 00817405023462 ()
  • 10817405023469 ()
ABTDOAW110401A

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

STATCUP® II - 00816036025388

STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATII-4267-0
In Commercial Distribution

  • 00816036025388 ()
  • 00816036025395 ()
STATII-4267-0

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