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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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
The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.
NONAGON LTD
N9
In Commercial Distribution

  • 07290018446102 ()
  • 17290018446109 ()
MHD-100-02-001

  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672770 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672794 Tyto Stethoscope and 7290016672800 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672760 when packed in 6 pack and with 27290016672767 when packed in 48 pack.
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 07290016672763 ()
900-00015-064

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoPro used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672787 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672817 Tyto Stethoscope and 07290016672824 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672753 when packed in 6 pack and with 27290016672750 when packed in 48 pack.
TYTO CARE LTD
TytoPro G2
In Commercial Distribution

  • 07290016672756 ()
900-00002-062

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672685 when packed in 6 pack and with 27290016672682 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672685 ()
  • 07290016672688 ()
  • 27290016672682 ()
900-00015-063

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades. This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545.
TYTO CARE LTD
TytoPro G2 US
In Commercial Distribution

  • 07290016672541 ()
  • 17290016672548 ()
  • 27290016672545 ()
900-00002-007

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672487 ()
  • 07290016672480 ()
  • 27290016672484 ()
900-00015-004

  • 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, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672425 when packed in 6 pack and with 27290016672422 when packed in 48 pack .
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672425 ()
  • 07290016672428 ()
  • 27290016672422 ()
900-00015-009

  • 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, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672302.
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672302 ()
  • 07290016672305 ()
900-00015-006

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672367 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672296 and 54 pack logistic carton labeled with 27290016672293.
TYTO CARE LTD
TytoPro US
In Commercial Distribution

  • 07290016672299 ()
  • 17290016672296 ()
  • 27290016672293 ()
900-00002-005

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
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
SELECT TL3 toilet bracket, for wall outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372778 ()
R9143000

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for wall outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372761 ()
R9143112

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for floor outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372693 ()
R9133000

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for floor outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372686 ()
R9133112

  • Height-adjustable toilet bracket, electric
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC) and Cocaine and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601587
Not in Commercial Distribution

  • 00690286000131 ()
  • 10690286000138 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
BIOMERIEUX , INC.
900-00003
In Commercial Distribution

  • 00860007326912 ()


  • Package sealing unit
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOB
Not in Commercial Distribution

  • 00858998006173 ()
USSCupA-7MOB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI2000/AMP/MET/PCP/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-7BP CM
Not in Commercial Distribution

  • 00858998006166 ()
USSCupA-7BP CM

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

  • 00724995200954 ()
LAH14IN02T

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

  • 00724995200961 ()
LAH14INNDT

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

  • 00724995200947 ()
LAH14IN01T

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

  • 00724995200930 ()
LAH14NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200923 ()
LAH14NC02

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

  • 00724995200916 ()
LAH14NC01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200879 ()
LAS31NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 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

  • 00724995200862 ()
LAS31NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 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

  • 00724995200855 ()
LAS31NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214326 ()
LES14NCND

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214319 ()
LES14NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214302 ()
LES14NC01

  • 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 is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214173 ()
LEH14INND

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214166 ()
LEH14IN02

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214159 ()
LEH14IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007581 ()
  • 30855944007582 ()
ACDOA-6125B-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007574 ()
  • 30855944007575 ()
ACDOA-6125B-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (10 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007567 ()
  • 30855944007568 ()
ACDOA-6125B-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007298 ()
  • 00855944007291 ()
  • 30855944007292 ()
ACDOA-6125B-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007281 ()
  • 00855944007284 ()
  • 30855944007285 ()
ACDOA-6125B-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731989 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731972 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731965 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Single High Density M5 without Control 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

  • 00724995166533 ()
LMH06NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Air Dual M7/M5 High Density 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

  • 00724995166038 ()
LMH08NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual Light with Single Flat Panel Monitor Mount, No Camera, Fixed is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192136 ()
LG11F

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Light with Single Flat Panel Monitor Mount, Non Camera, Fixed is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191993 ()
LG07F

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Dual Package with Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191436 ()
LM02

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