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Found 10 results
510(k) Data Aggregation
K Number
K032154Device Name
G-FREEZEKIT BLAST
Manufacturer
VITROLIFE AB
Date Cleared
2004-05-07
(298 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Media for freezing of blastocyst stage embryos
Device Description
MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
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K Number
K032155Device Name
G-THAWKIT BLAST
Manufacturer
VITROLIFE AB
Date Cleared
2004-05-07
(298 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Media for thawing of blastocyst stage embryos
Device Description
MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
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K Number
K022730Device Name
PERFADEX SOLUTION FOR LUNG PRESERVATION
Manufacturer
VITROLIFE AB
Date Cleared
2003-10-27
(437 days)
Product Code
MSB
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Device Description
Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution.
Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag.
Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature.
Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use.
The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.
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K Number
K000619Device Name
SCANDINAVIAN IVF SCIENCES AB, G2.2
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-06-27
(131 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000627Device Name
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-06-13
(117 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000625Device Name
SCANDINAVIAN IVF SCIENCES AB, G1.2
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-05-23
(96 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000626Device Name
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-05-23
(96 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000618Device Name
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-05-17
(90 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000621Device Name
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-05-16
(89 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000623Device Name
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
Manufacturer
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
Date Cleared
2000-05-16
(89 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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