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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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ClearRead Xray Pneumothorax - M722XC25114P250640

ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25114P250640 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722XC25064P250640

ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25064P250640 ()


  • Radiological PACS software

ClearRead Xray | Pneumothorax - M722XC22145P212210

ClearRead Xray Pneumothorax on Console Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XC22145P212210 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722X25122P250640

ClearRead Xray Server Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722X25122P250640 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722X25064P250640

ClearRead Xray Server Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722X25064P250640 ()


  • Radiological PACS software

ClearRead Xray | Pneumothorax - M722X22145P212210

ClearRead Xray Pneumothorax on Xray Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722X22145P212210 ()


  • Radiological PACS software

CorVista® System with PH Add-On - 00869059000443

CorVista System with PH Add-On
Analytics for Life Inc.
CorVista System with PH Add-On
In Commercial Distribution

  • 00869059000443 ()


  • Multiparameter physiologic analysis workstation

NA - 00869202000214

No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution

  • 00869202000214 ()


  • Blood bank information system application software

Regulated Software Application (RSA) - 00860664000309

The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of their blood banking processes. This system encapsulates the data access and business rules necessary for enabling blood collections, manufacturing, labeling, and distribution management efforts. Additionally, certain modules have associated administration function that creates traceability and accountability for every step of the blood banking process. The system utilizes technology standards that provide the robustness necessary for supporting web-enabled applications that interface with disparate systems. The application has been developed in a modular format.
ONEBLOOD, INC.
1.0.19.0
Not in Commercial Distribution

  • 00860664000309 ()
1.0.19.0

  • Blood bank information system application software

Blood Product Administration Module - 00860475000345

No Description
EPIC SYSTEMS CORPORATION
2
In Commercial Distribution

  • 00860475000345 ()


  • Blood bank information system application software
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