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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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EMAG software (virtual) version 1.3 also called SP3
BIOMERIEUX SA
1.3
In Commercial Distribution

  • 03573026613358 ()


  • Nucleic acid sample preparation instrument IVD
V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.2.0
In Commercial Distribution

  • 00814905020137 ()


  • Parenteral-nutrition management software
V2.1.3 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.3
In Commercial Distribution

  • 00814905020021 ()


  • Parenteral-nutrition management software
V2.1.2 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.2
In Commercial Distribution

  • 00814905020014 ()


  • Parenteral-nutrition management software
V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.1
In Commercial Distribution

  • 00814905020007 ()


  • Parenteral-nutrition management software
UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647046 ()
302.4018

  • Radiology DICOM image processing application software
v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution

  • 00817100020407 ()


  • Diagnostic x-ray digital imaging system workstation application software
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