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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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BioHorizons - 00847236015886

IntraSpin Rotor, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BROTORZ
In Commercial Distribution

  • 00847236015886 ()


  • Centrifuge rotor, ultracentrifuge

BioHorizons - 00847236015879

IntraSpin Power Cord, 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER220Z
In Commercial Distribution

  • 00847236015879 ()


  • Electrical mains power cable

BioHorizons - 00847236015862

IntraSpin Power Cord, 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER110Z
In Commercial Distribution

  • 00847236015862 ()


  • Electrical mains power cable

BioHorizons - 00847236015855

IntraSpin Hex Key, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BHEXZ
In Commercial Distribution

  • 00847236015855 ()


  • Haematological concentrate system

BioHorizons - 00847236015848

IntraSpin Fuse 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE220Z
In Commercial Distribution

  • 00847236015848 ()


  • Haematological concentrate system

BioHorizons - 00847236015831

IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution

  • 00847236015831 ()


  • Haematological concentrate system

BioHorizons - 00847236015824

IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution

  • 00847236015824 ()


  • Haematological concentrate system

BioHorizons - 00847236015817

IntraSpin Centrifuge, 110 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS110Z
In Commercial Distribution

  • 00847236015817 ()


  • Haematological concentrate system

Cyclone Platelet Rich Plasma (PRP) Concentrating System - M686CYCP60020

No Description
ALLIANCE PARTNERS LLC
CYCP-60-02
In Commercial Distribution

  • M686CYCP60020 ()
CYCP-60-02

  • Haematological concentrate system

Cyclone Concentrating System - M686CYC60020

No Description
ALLIANCE PARTNERS LLC
CYC-60-02
In Commercial Distribution

  • M686CYC60020 ()
CYC-60-02

  • Haematological concentrate system

Cyclone Concentrating System - M686CYC120020

No Description
ALLIANCE PARTNERS LLC
CYC-120-02
In Commercial Distribution

  • M686CYC120020 ()
CYC-120-02

  • Haematological concentrate system

Ultra Transfusion Medicine - 05060508820031

Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution

  • 05060508820031 ()


  • Blood bank information system application software

Ortho Connect - 05060496770066

ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution

  • 05060496770066 ()


  • Laboratory instrument/analyser application software IVD

Sanguin Liberty SRIMPORT - 05060496770059

The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution

  • 05060496770059 ()


  • Blood bank information system application software

ORTHO CONNECT - 05060496770028

ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results of testing, assigns outcomes to individual samples according to a configured rule, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution

  • 05060496770028 ()


  • Blood bank information system application software

Procleix NAT Manager - 05060496770011

Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution

  • 05060496770011 ()


  • Blood bank information system application software

cobas Synergy - 05060496770004

cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution

  • 05060496770004 ()


  • Blood bank information system application software

ALBAcyte IgG Sensitized Red Blood Cells - 05060242471162

ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control

Thermo Scientific - 10850685007002

No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution

  • 10850685007002 ()
75007504

  • Cell washer IVD

TRANSWAAG - 04028339620139

Blood mixing and weighing device
Transmed Medizintechnik GmbH & Co. KG
TRANSWAAG PRO
In Commercial Distribution

  • 04028339620139 ()
97.8700.105

  • Blood weighing scale

ePROGESA - 03665324000050

No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system

ePROGESA - 03665324000036

No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system

Patient Health Software (P.H.S) - 03665324000005

No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system

Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter - M5264C23041

For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set

Eurotrol - 08718734960409

Assayed Quality control solution
Eurotrol B.V.
188.003.002
In Commercial Distribution

  • 08718734960409 ()
  • 08718734960416 ()
188.003.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960386

Assayed Quality control solution
Eurotrol B.V.
188.002.002
In Commercial Distribution

  • 08718734960386 ()
  • 08718734960393 ()
188.002.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960362

Assayed Quality control solution
Eurotrol B.V.
188.001.002
In Commercial Distribution

  • 08718734960362 ()
  • 08718734960379 ()
188.001.002

  • Total haemoglobin (totHb) IVD, control

RegenKit®-BCT-3 - 08500331310066

No Description
Regenlab USA LLC
RK-BCT-3
Not in Commercial Distribution

  • 08500331310066 ()


  • Haematological concentrate system preparation kit, platelet concentration

A-CP-Kit-3 - 08500331310011

No Description
Regenlab USA LLC
A-CP-3
Not in Commercial Distribution

  • 08500331310011 ()


  • Haematological concentrate system preparation kit, platelet concentration

ID CORE CONTROL - 08437013457040

The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control

Maximus Processing System Blood PRP Kit - B73810071

To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution

  • B73810071 ()


  • Haematological concentrate system

World PRP - 10754016214124

No Description
Luvo Medical Technologies Inc
WORLDPRP
In Commercial Distribution

  • 00754016214127 ()
  • 10754016214124 ()


  • Haematological concentrate system preparation kit, platelet concentration

CryoStore Freezing Bag - 10816203024319

CryoStore 50 EVA Freezing Bag, 10-30ml, "M3" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203024316 ()
  • 10816203024319 ()
  • 00816203024312 ()
CS50M3

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024302

CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS30M9
In Commercial Distribution

  • 20816203024309 ()
  • 10816203024302 ()
CS30M9

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024289

CryoStore 500 EVA Freezing Bag, 55-100ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution

  • 20816203024286 ()
  • 10816203024289 ()
  • 00816203024282 ()
CS500

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024258

CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250
In Commercial Distribution

  • 20816203024255 ()
  • 10816203024258 ()
  • 00816203024251 ()
CS250

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024241

CryoStore 50 EVA Freezing Bag, 10-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution

  • 20816203024248 ()
  • 10816203024241 ()
  • 00816203024244 ()
CS50N

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024234

CryoStore 50 EVA Freezing Bag, 10-30ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50
In Commercial Distribution

  • 20816203024231 ()
  • 10816203024234 ()
  • 00816203024237 ()
CS50

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024227

CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set, 8" donor tube
ORIGEN BIOMEDICAL, INC.
CS25XN
In Commercial Distribution

  • 20816203024224 ()
  • 10816203024227 ()
  • 00816203024220 ()
CS25XN

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024210

CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203024217 ()
  • 10816203024210 ()
  • 00816203024213 ()
CS25N

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024203

CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25F
In Commercial Distribution

  • 20816203024200 ()
  • 10816203024203 ()
  • 00816203024206 ()
CS25F

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024067

CryoStore 28 EVA Freezing Bag, 10-25ml, "V" Tube Set
ORIGEN BIOMEDICAL, INC.
CS28V
In Commercial Distribution

  • 20816203024064 ()
  • 10816203024067 ()
  • 00816203024060 ()
CS28V

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024050

CryoStore 25 EVA Freezing Bag, 10-25ml, "Y4" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25Y4
In Commercial Distribution

  • 20816203024057 ()
  • 10816203024050 ()
  • 00816203024053 ()
CS25Y4

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203023909

CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS25FP
In Commercial Distribution

  • 20816203023906 ()
  • 10816203023909 ()
CS25FP

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203023756

CryoStore 250 EVA Freezing Bag, 30-70ml, K Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250KS
In Commercial Distribution

  • 20816203023753 ()
  • 10816203023756 ()
CS250KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023749

CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS750KS
In Commercial Distribution

  • 20816203023746 ()
  • 10816203023749 ()
CS750KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023732

CryoStore 500 EVA Freezing Bag, 55 - 100ml "K" Tube Set, double aseptically packed.
ORIGEN BIOMEDICAL, INC.
CS500KS
In Commercial Distribution

  • 20816203023739 ()
  • 10816203023732 ()
CS500KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023725

CryoStore 50 EVA Freezing Bag,10-30ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS50KS
In Commercial Distribution

  • 20816203023722 ()
  • 10816203023725 ()
CS50KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023640

CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250S
In Commercial Distribution

  • 20816203023647 ()
  • 10816203023640 ()
CS250S

  • Blood/tissue storage/culture container

CryoStore - 10816203023589

CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “V” Tube Set
ORIGEN BIOMEDICAL, INC.
CS20V6
In Commercial Distribution

  • 20816203023586 ()
  • 10816203023589 ()
CS20V6

  • Blood/tissue storage/culture container
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