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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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A sterile, tubular, semi-rigid, hand-held device with a permanently-integrated winged base. The cannula has a single large "scoop cut" type of opening and has no sharp edges. Cannulae, regardless of size, have a number identifying the size of the cannula. The cannulae are color-coded and use adapters with the same color-coding. Cannulae are sealed into packaging and sterilized.
WOMANCARE GLOBAL TRADING, INC.
SR10
In Commercial Distribution

  • 00853615006093 ()

  • Thickness : 0.5mm to 1.3mm
  • Length: 223 Millimeter


  • Suction cannula, reusable
WINGS
MEDACURE INC.
PW2018
In Commercial Distribution

  • 00853223008106 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
No Description
JACE MEDICAL, LLC
115.701.04
Not in Commercial Distribution

  • 00853190008376 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario USB-C Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1193-05
In Commercial Distribution

  • 00850065006505 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
  • Glucose monitoring system IVD, home-use
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario LC Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1183-05
In Commercial Distribution

  • 00850065006451 ()


  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD through a USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006390) The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)
LABSTYLE INNOVATION LTD
1200-05
In Commercial Distribution

  • 00850065006406 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
  • Glucose monitoring system IVD, home-use
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006154) The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)
LABSTYLE INNOVATION LTD
1147-05
In Commercial Distribution

  • 00850065006253 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
  • Glucose monitoring system IVD, home-use
Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution

  • 05706069659788 ()
8 393 0101 112

  • Hearing aid remote control application software
No Description
Etac Immedia A/S
MultiGlide lateral S
In Commercial Distribution

  • 05708012499205 ()
IM66

  • Patient transfer sliding mat
No Description
Etac Immedia A/S
MultiGlide SG lateral S
In Commercial Distribution

  • 05708012499199 ()
IM0066

  • Patient transfer sliding mat
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