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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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Thirteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007744

Thirteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-2135AD
In Commercial Distribution

  • 00850557007744 ()
  • 00850557007751 ()
  • 10850557007758 ()


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

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007706

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-6125AD
In Commercial Distribution

  • 00850557007706 ()
  • 00850557007713 ()
  • 10850557007710 ()


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

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007645

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-7104AD
In Commercial Distribution

  • 00850557007645 ()
  • 00850557007652 ()
  • 10850557007659 ()


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

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007560

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-3104AD
In Commercial Distribution

  • 00850557007560 ()
  • 00850557007577 ()
  • 10850557007574 ()


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

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007607

Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-4104AD
In Commercial Distribution

  • 00850557007607 ()
  • 00850557007614 ()
  • 10850557007611 ()


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

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00851000007106

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MOP | MTD | OXY | PCP| TCA | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-7125AD
In Commercial Distribution

  • 10851000007110 ()
  • 00851000007113 ()
  • 00851000007106 ()


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

Twelve Panel Clear Scan Drug Test Cup With Adulterants - 00851000007021

Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC With Adulterants
MERGERS MARKETING, INC.
CSC-6125AD
In Commercial Distribution

  • 10851000007035 ()
  • 00851000007038 ()
  • 00851000007021 ()


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

Thirteen Panel Clear Scan Drug Test Cup With Adulterants - 00851000007007

Thirteen Panel Clear Scan Drug Test Cup With Adulterants Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC + AD
MERGERS MARKETING, INC.
CSC-2135 AD
In Commercial Distribution

  • 10851000007011 ()
  • 00851000007014 ()
  • 00851000007007 ()


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

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup - 10817038022068

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038022065 ()
  • 10817038022068 ()
  • 00817038022061 ()
U-DUD-20124

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

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup - 10817038022044

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038022041 ()
  • 10817038022044 ()
  • 00817038022047 ()
U-DUD-20124

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

Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/CAT - 00850018892094

Customizable medical panel insert capable of being oriented vertically or horizontally to fit inside a variety of backpacks or messenger-style bags via a unique hinge system.
Altitude Technologies Inc.
01246CB-CAT
In Commercial Distribution

  • 00850018892094 ()
1246CB-CAT

  • First aid kit, non-medicated, single-use

Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/SOFTT-W - 00850018892056

Customizable medical panel insert capable of being oriented vertically or horizontally to fit inside a variety of backpacks or messenger-style bags via a unique hinge system.
Altitude Technologies Inc.
01246CB
In Commercial Distribution

  • 00850018892056 ()
1246CB

  • First aid kit, non-medicated, single-use

OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel - 00813382010396

KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel - 00813382010389

KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel - 00813382010372

KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

QuickProfile™ Drugs of Abuse Panel 7 Test Card - M90107RD718402A0

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7184-02A
In Commercial Distribution

  • M90107RD718402A1 ()
  • M90107RD718402A0 ()

  • Length: 75 Millimeter
07RD7184-02A

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

QuickProfile™ Drugs of Abuse Panel 3 Test Card - M90107RD709311A0

Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
LUMIQUICK DIAGNOSTICS, INC.
07RD7093-11A
In Commercial Distribution

  • M90107RD709311A1 ()
  • M90107RD709311A0 ()

  • Length: 75 Millimeter
07RD7093-11A

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

Lambda Cell Tray™ 60 T Cell Panel - Sample - 00812117018751

Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018751 ()
LCT1W60S

  • HLA class I & II antibody screening IVD, kit, multiplex

HarmonyAIR - 00724995167370

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

  • 00724995167370 ()
P056939299

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

HarmonyAIR - 00724995167158

The G5 Dual Light with Camera, No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167158 ()
LGH12NT

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

HarmonyAIR - 00724995166588

The Single High Density M5, No Control with Single Flat Panel Monitor, Spring Arm is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166588 ()
LMH24N

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

HarmonyAIR - 00724995165680

The Single M5 without Control with Single Flat Panel Monitor, Spring Arm and Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165680 ()
LM24NT

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

HarmonyAIR - 00724995165659

The Single M5 without Control with Single M5 with Single Flat Panel Monitor, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165659 ()
LM04NT

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

HarmonyAIR - 00724995214388

The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214388 ()
LES14NCNDT

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

HarmonyAIR - 00724995214371

The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214371 ()
LES14NC02T

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

HarmonyAIR - 00724995214364

The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214364 ()
LES14NC01T

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

HarmonyAIR - 00724995214234

The E-Series High Density Dual Light, Dual Flat Panel Monitor, No Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214234 ()
LEH14INNDT

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

HarmonyAIR - 00724995214227

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214227 ()
LEH14IN02T

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

HarmonyAIR - 00724995214210

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214210 ()
LEH14IN01T

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

HarmonyAIR - 00724995214111

The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, No Camera is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214111 ()
LES31NCND

  • Medical monitor/light mount
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