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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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TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672213 ()
900-00015

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672053 ()
  • 17290016672050 ()
900-00015

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036.
TYTO CARE LTD
TytoPro
In Commercial Distribution

  • 07290016672039 ()
  • 17290016672036 ()
900-00002

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 27290018446151 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 17290018446154 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
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
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
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
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
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
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
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