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510(k) Data Aggregation
K Number
K032827Device Name
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
Manufacturer
Date Cleared
2003-12-08
(89 days)
Product Code
Regulation Number
864.9100Why did this record match?
Product Code :
KSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.
Device Description
The Kendall LifeTrace Umbilical Blood Collection Device consists of a cup shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half contains an Angel Wing Transfer device that is used to facilitate the transfer of the collected blood from the top chamber to the tube.
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K Number
K020753Device Name
DEROYAL SURGICAL, UMBILICUP
Manufacturer
Date Cleared
2002-06-13
(98 days)
Product Code
Regulation Number
864.9100Why did this record match?
Product Code :
KSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
a single use only, cord blood sampling, transfer device.
The Umbilicup is suitable for vaginal delivery and caesarean delivery.
The Umbilicup reduces blood exposure and aids in blood gas collection and transport.
Device Description
A blood collection/transfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width.
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