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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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Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database
FENWAL, INC.
2.2
In Commercial Distribution

  • 00811137013050 ()
5S9804

  • Blood bank information system application software
  • Medical equipment clinical data interfacing software
EV1000 VOLUMEVIEW CABLE
Edwards Lifesciences LLC
EVVVTC1
In Commercial Distribution

  • 00690103190151 ()

  • Length: 93 Inch
EVVVTC1

  • Electrical-only medical device connection cable, reusable
  • Patient positioning sensor
Hand Held Fundus Camera EFC-1800
U.S. OPHTHALMIC, L.L.C.
EFC-1800
In Commercial Distribution

  • 00850038195229 ()


  • Ophthalmic fundus camera
No Description
1BYONEPRODUCTS INC.
TMB-1585-BS
In Commercial Distribution

  • 00850014261016 ()
  • 10850014261013 ()


  • Telemetric sphygmomanometer
NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).
NIDEK CO.,LTD.
DS-20 Control Unit
In Commercial Distribution

  • 04987669101087 ()


  • Ophthalmic fundus camera
NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-20F
In Commercial Distribution

  • 04987669101001 ()


  • Ophthalmic fundus camera
NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-10F
In Commercial Distribution

  • 04987669100998 ()


  • Ophthalmic fundus camera
The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.
Cellview Imaging Inc.
01
In Commercial Distribution

  • 00628678036017 ()


  • Ophthalmic fundus camera
KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
KOWA COMPANY,LTD.
K9L64K
In Commercial Distribution

  • 04987646809128 ()


  • Ophthalmic fundus camera
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
KOWA COMPANY,LTD.
DE2K
Not in Commercial Distribution

  • 04987646807728 ()


  • Ophthalmic fundus camera
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