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Plasma Thawing System
CYTOTHERM LP
CT-4T.6C
In Commercial Distribution
- 00861128000323 ()
- Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T
In Commercial Distribution
- 00861128000316 ()
- Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4S
In Commercial Distribution
- 00861128000309 ()
- Cryopreserved blood/tissue thawing unit
The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
BELL-82380-A
In Commercial Distribution
- 00861122000312 ()
- 10861122000319 ()
BELL-82380-A
- Haematological concentrate system preparation kit, platelet concentration
The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
CELL-80180-A
In Commercial Distribution
- 10861122000302 ()
- 00861122000305 ()
CELL-80180-A
- Haematological concentrate system preparation kit, platelet concentration
No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution
- 00869202000214 ()
- Blood bank information system application software
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 Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as 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.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution
- 00866305000264 ()
- Length: 33 Centimeter
- Height: 9.9 Centimeter
- Width: 14.2 Centimeter
- Weight: 2.5 Kilogram
480-RW-2607-02
- Laboratory tubing welder
The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution
- 00866305000219 ()
- Weight: 1.6 Kilogram
- Width: 9.1 Centimeter
- Length: 27.2 Centimeter
- Height: 5.9 Centimeter
480-B40-00-1245
- Laboratory tubing welder
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
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as 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.
718463
In Commercial Distribution
- 00866489000012 ()
718463
- Electronic pipette
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution
- 00866305000202 ()
- Weight: 2.5 Kilogram
- Width: 14.2 Centimeter
- Height: 9.9 Centimeter
- Length: 33 Centimeter
480-RW-2607-00
- Laboratory tubing welder
No Description
Roche Molecular Systems, Inc.
09040528190
In Commercial Distribution
- 00875197006384 ()
09040528190
- HIV1/HIV2 nucleic acid IVD, control
Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.
AMERICAN NATIONAL RED CROSS
510395
In Commercial Distribution
- 00858400005084 ()
- Multiple immunohaematology test IVD, control
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
AMERICAN NATIONAL RED CROSS
510400/510402
In Commercial Distribution
- 20858400005095 ()
- 00858400005091 ()
- 10858400005098 ()
- Immunoglobulin-sensitized reagent red blood cell IVD, control
Autologous Platelet System - PRFM
Musculoskeletal Transplant Foundation, Inc.
910050
Not in Commercial Distribution
- 00859070006036 ()
910050
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution
- 00859070006012 ()
910044
- Haematological concentrate system preparation kit, platelet concentration
No Description
SCC SOFT COMPUTER
1.0.0.17
In Commercial Distribution
- 00859474006946 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
4.5.4.1
In Commercial Distribution
- 00859474006656 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.6.1.0
In Commercial Distribution
- 00859474006601 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.16
In Commercial Distribution
- 00859474006526 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.1
In Commercial Distribution
- 00859474006458 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.15
In Commercial Distribution
- 00859474006328 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.3.4
In Commercial Distribution
- 00859474006311 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.6.0
In Commercial Distribution
- 00859474006304 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.3.1.1
In Commercial Distribution
- 00859474006281 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.5.0
In Commercial Distribution
- 00859474006243 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.4.2
In Commercial Distribution
- 00859474006236 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.14
In Commercial Distribution
- 00859474006229 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.4.1
In Commercial Distribution
- 00859474006205 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.3.1
In Commercial Distribution
- 00859474006175 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.13
In Commercial Distribution
- 00859474006151 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
4.5.4.0
In Commercial Distribution
- 00859474006137 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.1.3.1
In Commercial Distribution
- 00859474006113 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.3.3
In Commercial Distribution
- 00859474006090 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.12
In Commercial Distribution
- 00859474006083 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.3.2
In Commercial Distribution
- 00859474006069 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.11
In Commercial Distribution
- 00859474006045 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.4.0
In Commercial Distribution
- 00859474006038 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.2.1
In Commercial Distribution
- 00859474006021 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.3.1.0
In Commercial Distribution
- 00859474006014 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.1.3.0
In Commercial Distribution
- 00859474006007 ()
- Blood bank information system application software
Autologous Platelet System-PRFM x 2
Musculoskeletal Transplant Foundation, Inc.
910048
Not in Commercial Distribution
- 00859070006043 ()
910048
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - PRP X 2
Musculoskeletal Transplant Foundation, Inc.
910047
Not in Commercial Distribution
- 00859070006029 ()
910047
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution
- 00859070006005 ()
910046
- Haematological concentrate system preparation kit, platelet concentration
This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Reapplix ApS
2
In Commercial Distribution
- 05714188505503 ()
- Haematological concentrate system preparation kit, platelet concentration
This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution
- 05714188505206 ()
- Haematological concentrate system preparation kit, platelet concentration