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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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Clear Arch Mobile - 00817644020185

Remote Patient Monitoring Application
Mobilehelp, LLC
1
In Commercial Distribution

  • 00817644020185 ()


  • Home healthcare information system application software

Code-Stat Version 10.1 - 00883873863589

LIFEPAK SDK COMPATIBLE WITH CODE-STAT V10.1
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873863589 ()
21340-000841

  • Medical equipment clinical data interfacing software

Sunquest Laboratory - B236LAB8230

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
8.2.3
Not in Commercial Distribution

  • B236LAB8230 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB8130

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
8.1.3
Not in Commercial Distribution

  • B236LAB8130 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB8010

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
8.0.1
Not in Commercial Distribution

  • B236LAB8010 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB10110

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
10.1.1
Not in Commercial Distribution

  • B236LAB10110 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB10010

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
10.0.1
Not in Commercial Distribution

  • B236LAB10010 ()


  • Clinical laboratory information system application software

SoftHLA - 00810055819256

No Description
SCC SOFT COMPUTER
4.1.17.241
In Commercial Distribution

  • 00810055819256 ()


  • Clinical laboratory information system application software

SoftFlowcytometry - 00810055819249

No Description
SCC SOFT COMPUTER
4.1.17.241
In Commercial Distribution

  • 00810055819249 ()


  • Clinical laboratory information system application software

SoftCytogenetics - 00810055819225

No Description
SCC SOFT COMPUTER
4.1.17.241
In Commercial Distribution

  • 00810055819225 ()


  • Clinical laboratory information system application software
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