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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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RHYTHMIA HDx™ - 08714729938569

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG60
In Commercial Distribution

  • 08714729938569 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938552

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG30
In Commercial Distribution

  • 08714729938552 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938545

Localization Generator Cable
BOSTON SCIENTIFIC CORPORATION
M004RA71010
In Commercial Distribution

  • 08714729938545 ()
M004RA71010

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938538

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110I0
In Commercial Distribution

  • 08714729938538 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938521

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110A0
In Commercial Distribution

  • 08714729938521 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938514

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010I0
In Commercial Distribution

  • 08714729938514 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938507

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010A0
In Commercial Distribution

  • 08714729938507 ()


  • Electrocardiographic lead set, reusable

Fenwal DXT Relay - 00811137013050

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 - 00690103190151

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

Eli Ezer - 00850038195229

Hand Held Fundus Camera EFC-1800
U.S. OPHTHALMIC, L.L.C.
EFC-1800
In Commercial Distribution

  • 00850038195229 ()


  • Ophthalmic fundus camera
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