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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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
Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP25 THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-H6-3-AZ25
In Commercial Distribution

  • 00850013036004 ()
  • 10850013036001 ()
ID-H6-3-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR300, OXY100 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US6-BUP
In Commercial Distribution

  • 00850013035144 ()
  • 10850013035141 ()
ID-US6-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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 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 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
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
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) 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) 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) 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
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
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 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
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
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
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
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
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
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
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
INFIMED, INC.
Nexus DRF (RF/DR)
Not in Commercial Distribution

  • 00858086006023 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF (RF/DR)
In Commercial Distribution

  • 00854344007078 ()


  • 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
MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA2K
In Commercial Distribution

  • 00868348000232 ()
71125AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA
In Commercial Distribution

  • 00868348000225 ()
71125AA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA2K
In Commercial Distribution

  • 00868348000218 ()
11125AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA
In Commercial Distribution

  • 00868348000201 ()
11125AA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200985 ()
LAH14NC02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series High Definition Dual Light, Dual Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200992 ()
LAH14NCNDT

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200978 ()
LAH14NC01T

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