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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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The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution

  • 04260160470020 ()
200100-US

  • Coagulation analyser IVD, laboratory, semi-automated
No Description
TCOAG IRELAND LIMITED
N04000
In Commercial Distribution

  • 05391521421012 ()


  • Coagulation analyser IVD, laboratory, semi-automated
No Description
TCOAG IRELAND LIMITED
G05000
In Commercial Distribution

  • 05391521421005 ()


  • Coagulation analyser IVD, laboratory, semi-automated
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446541
In Commercial Distribution

  • 00842768012358 ()
  • 00842768025006 ()
OVMN11

  • Coagulation analyser IVD, laboratory, semi-automated
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446530
In Commercial Distribution

  • 00842768012259 ()
  • 00842768024979 ()
OVKG03

  • Coagulation analyser IVD, laboratory, semi-automated
The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen
Siemens Healthcare Diagnostics Products GmbH
10458677
In Commercial Distribution

  • 00842768024887 ()
OVKF032

  • Coagulation analyser IVD, laboratory, semi-automated
No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated
TEMPERATURE PROBE
INSTRUMENTATION LABORATORY COMPANY
06320480210
In Commercial Distribution

  • 08426950452614 ()
06320480210

  • Coagulation analyser IVD, laboratory, semi-automated
Sebacia Microparticles Box of 9 vials
Coronado Aesthetics, LLC
SEB-250-3P-US
In Commercial Distribution

  • G256SEB2503PUS1 ()
  • G256SEB2503PUS0 ()

  • Total Volume: 3 Milliliter
SEB2503PUS

  • Photothermal therapy gel
Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution

  • 20850002391019 ()
  • 10850002391111 ()

  • Total Volume: 3 Milliliter
SEB-250-3P-US

  • Photothermal therapy gel
No Description
DIAGNOSTICA STAGO
00595
In Commercial Distribution

  • 13607450005957 ()
  • 03607450005950 ()


  • Activated partial thromboplastin time (APTT) IVD, kit, clotting
Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.
Bosma Enterprises
10-9030PTT
In Commercial Distribution

  • 10818634020304 ()
  • 00818634020307 ()
10-9030PTT

  • Pillow cover, single-use
  • Basic bed sheet, single-use
Electronic System Verification Tube
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HE-ESV
In Commercial Distribution

  • 10711234540053 ()
HE-ESV

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Report Maker V6.01
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
RPM-CD
In Commercial Distribution

  • 10711234540039 ()
RPM-CD

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Temperature Verification Cartridge
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
J-1001
In Commercial Distribution

  • 10711234540107 ()
J-1001

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Electronic System Verification - Abnormal
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
JEA-QC
In Commercial Distribution

  • 10711234540091 ()
JEA-QC

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Electronic System Verification - Normal
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
JEN-QC
In Commercial Distribution

  • 10711234540084 ()
JEN-QC

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Electronic System Verification Kit
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HE-J04
In Commercial Distribution

  • 10711234540077 ()
HE-J04

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
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