Search Results
Found 6 results
510(k) Data Aggregation
K Number
K102890Device Name
K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2010-10-21
(21 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
Device Description
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
Ask a Question
K Number
K030385Device Name
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2003-04-15
(69 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE IV ADD-ON FILTER ADMINISTRATION SET USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION DURING INTRAVASCULAR ADMINISTRATION. THE DEVICE MAY INCLUDE A NEELE FREE VALVE INJECTION SITE WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES.
Device Description
A STERILE, SINGLE USE ADD-ON FILTER ADMINISTRATION SET USED TO SERVE AS A CONDUIT FOR THE FILTRATION OF IV FLUID FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. THE DEVICE MAY INCLUDE A NEELELESS ACCESS CONECTOR WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES. THE FILTER PORE SIZE WILL BE .22 OR 1.2 MICRON WITH AN EFFECTIVE FILTRATION RATE (EFA) OF 10 CM2.
Ask a Question
K Number
K001423Device Name
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2000-07-21
(77 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001424Device Name
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2000-07-21
(77 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001426Device Name
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2000-07-21
(77 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001043Device Name
KAWASUMI LABORATORY BLOOD DRAWING KIT
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2000-05-19
(49 days)
Product Code
KSB
Regulation Number
864.9875Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1