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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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CRYPTO GIARDIA KIT
Cardinal Health 200, LLC
CH6830
In Commercial Distribution

  • 50885380096738 ()
  • 20885380096737 ()
  • 10885380096730 ()
CH6830

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical
Xpect Giardia/Crypto KT/20TST
REMEL, INC.
R2450520
In Commercial Distribution

  • 00848838026874 ()
  • 00848838099779 ()


  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-230
In Commercial Distribution

  • 00863152000331 ()


  • Limited-view-field CT system
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-115
In Commercial Distribution

  • 00863152000324 ()


  • Limited-view-field CT system
'One-piece ECG Monitor Cable AAMI
Unimed Medical Supplies, Inc.
E10R-SH2-B/I-N
In Commercial Distribution

  • 06936735465095 ()


  • Electrocardiographic lead set, reusable
Black Lancing Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005189 ()
OFG00204

  • Manual blood lancing device, reusable
Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005141 ()
OFG00156

  • Manual blood lancing device, reusable
Box of 1 Vial of 50 In Touch Test Strips
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005110 ()
OFG00154

  • Glucose IVD, reagent
6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005103 ()
KIT00147

  • Blood lancing device tip
  • Glucose IVD, control
  • Glucose IVD, reagent
In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005097 ()
KIT00145

  • Glucose monitoring system IVD, home-use
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