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Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9822M
In Commercial Distribution
- 06937572804450 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9825M
In Commercial Distribution
- 06937572804443 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9818M
In Commercial Distribution
- 06937572804436 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-98M
In Commercial Distribution
- 06937572804429 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-96M
In Commercial Distribution
- 06937572804412 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-95M
In Commercial Distribution
- 06937572804405 ()
- Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-93M
In Commercial Distribution
- 06937572804399 ()
- Air-conduction hearing aid, wearable case
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000421 ()
- Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000414 ()
- Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution
- 00867268000407 ()
- Blood bank information system application software
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges.
MEDICAL INFORMATION TECHNOLOGY, INC.
Expanse
In Commercial Distribution
- 00863529000148 ()
- Blood bank information system application software
No Description
EPIC SYSTEMS CORPORATION
2
In Commercial Distribution
- 00860475000345 ()
- Blood bank information system application software
No Description
EPIC SYSTEMS CORPORATION
3
In Commercial Distribution
- 00860475000314 ()
- Blood bank information system application software
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS).
ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution
- 10888234002475 ()
- Laboratory instrument/analyser application software IVD
GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTraP supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture.
KEDRION SPA
3.x.x.x
In Commercial Distribution
- 08055271669762 ()
- Blood bank information system 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