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Vital Sync Early Warning Score Application v1 Software with OUS Support
Covidien LP
EWSSW01
In Commercial Distribution
- 10884521762626 ()
- Multiparameter physiologic analysis workstation
Pyxis Transfusion Verification
CAREFUSION 303, INC.
TRANSFUSION
Not in Commercial Distribution
- 10885403421532 ()
- Blood bank information system application software
No Description
Heuron Co., Ltd.
ST-ICT01
In Commercial Distribution
- 08800086200217 ()
- Radiology DICOM image processing application software
Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000179 ()
- X-ray image interpretive software
Linux version
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000124 ()
- X-ray image interpretive software
Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution
- 00840682147231 ()
- X-ray image interpretive software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013406 ()
1151300010
- Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013383 ()
1151306010
- Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013376 ()
1151303010
- Medical equipment clinical data interfacing software
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Moon Surgical Inc
100
In Commercial Distribution
- 03770025849096 ()
- Surgical camera holder
No Description
MILVUE
V2.x.x
In Commercial Distribution
- 03770024774016 ()
- X-ray image interpretive software
The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
BAXTER INTERNATIONAL INC.
3570009
In Commercial Distribution
- 00085412610900 ()
3570009
- Bedside infusion pump, single-channel
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution
- B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution
- B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution
- B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2024 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device
(bidirectional) WellSky Transfusion 2024 provides customized control processes for transfusion management of all procedures
and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2024
In Commercial Distribution
- B105TRANSFUSION20240 ()
- Blood bank information system application software
WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2023 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device
(bidirectional) WellSky Transfusion 2023 provides customized control processes for transfusion management of all procedures
and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2023
Not in Commercial Distribution
- B105TRANSFUSION2023 ()
- Blood bank information system application software
WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage device (bi-directional)
WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2021
In Commercial Distribution
- B105TRANSFUSION2021 ()
- Blood bank information system application software
WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2020 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage device (bi-directional)
WellSky Transfusion 2020 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2020
In Commercial Distribution
- B105TRANSFUSION2020 ()
- Blood bank information system application software
WellSky Tranfusion 2019 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2015 R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage device (bi-directional)
WellSky Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2019
In Commercial Distribution
- B105TRANSFUSION20190 ()
- Blood bank information system application software
WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling, there is no hardware or other components included in the final product. WellSky™ Transfusion 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage devices (bi-directional)
WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety
WELLSKY CORPORATION
2018
In Commercial Distribution
- B105TRANSFUSION20180 ()
- Blood bank information system application software
WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)
WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures and
testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2022
In Commercial Distribution
- B105TRANSFUSION0 ()
- Blood bank information system application software
LifeTrak 2012 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2012
In Commercial Distribution
- B105LIFETRAK0 ()
- Blood bank information system application software
HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)
HCLL 2015R2 provides customized control processes for transfusion management of all procedures and
testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2015R2
In Commercial Distribution
- B105HCLL0 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2023
In Commercial Distribution
- B105BLOODCENTERS2023 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2019
In Commercial Distribution
- B105BLOODCENTERS2019 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2018
In Commercial Distribution
- B105BLOODCENTERS2018 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2022
In Commercial Distribution
- B105BLOODCENTERS0 ()
- Blood bank information system application software
WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit.
WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation.
WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data.
WELLSKY CORPORATION
2020
In Commercial Distribution
- B105BLOOD2020 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2024
In Commercial Distribution
- B10520241 ()
- Blood bank information system application software