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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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Nonagon N9+ SmartExam - 27290018446151

No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 27290018446151 ()


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

Nonagon N9+ - 17290018446154

No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 17290018446154 ()


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

Nonagon - 07290018446102

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 - 07290016672763

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 - 07290016672756

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 - 07290016672688

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

TytoPro - 07290016672541

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 - 07290016672480

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 - 07290016672428

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 - 07290016672305

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

TytoPro - 07290016672299

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 - 07290016672213

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 - 07290016672053

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

TytoPro - 07290016672039

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 - 05708590372778

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 - 05708590372761

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 - 05708590372693

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 - 05708590372686

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

VERDICT®-II - 00690286000131

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

VITEK® REVEAL™ SEALER - 00860007326912

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
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