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510(k) Data Aggregation
K Number
K991005Device Name
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
Manufacturer
DAYSPRING MEDICAL, INC.
Date Cleared
1999-06-22
(89 days)
Product Code
LLB
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
DAYSPRING MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are used for capping off the two dialysate port access ends of a hollow fiber dialyzer. The devices are used by technicians in a dialysis unit during the cleaning, reprocessing, and disinfecting of the dialyzer. During the disinfecting procedure, the technician fills the dialyzer with a sterilant solution that sterilizes the inner filter membrane of the dialyzer. The dialysate port caps prevent the large-scale leakage of the fluid stored inside the dialyzer. The vented dialysate port caps, in the process of venting pressure, may leak a very small amount of fluid. The device replaces the original equipment manufacturer's closure ports after the initial use of the dialyzer.
Device Description
The devices are clean, but not sterile. The inside opening of the caps are tapered to match the standard dialysate ports found on hollow fiber dialyzers. The devices mate directly to the dialysate port. The caps are affixed by placing the open end of the cap over the "male" end of the dialysate ports. They are released by pulling them straight off. The surface of the dialysate port and the surface of the dialysate port cap device meet, and create a friction seal that prevents stored fluids from leaking out of the dialyzer. The vented dialysate port cap has a po-up piece at the top of the device. These vented caps are specifically for use with a sterilant solution known as Renalin, and manufactured by Minntech Corp. This sterilant is known to create pressure inside the dialyzer. The vented cap is a device to relieve this pressure buildup.
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K Number
K991003Device Name
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
Manufacturer
DAYSPRING MEDICAL, INC.
Date Cleared
1999-06-09
(76 days)
Product Code
FKY
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
DAYSPRING MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a sample of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile.
The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.
Device Description
Pump Segment Rinse Lines & T-Connectors
Pump segment rinse line w/ slip-on connector (Our Catalog No. PS100R)
Pump segment rinse line w/ luer-lock connector (Our Catalog No. PS100B)
T-connector, short, w/ slip-on connector (Our Catalog No. ST100R)
T-connector, short, w/ luer-lock connector (Our Catalog No. ST100B)
T-connector, long, w/ slip-on connector (Our Catalog No. LT100R)
T-connector, long, w/ luer-lock connector (Our Catalog No. LT100B)
The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector.
The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.
The luer-lock, screw-on connector securely screws on to the "male" end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frotion seal that prevents any fluids from leaking out of the dia
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K Number
K961039Device Name
BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL
Manufacturer
DAYSPRING MEDICAL, INC.
Date Cleared
1996-09-12
(182 days)
Product Code
FJI
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
DAYSPRING MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961040Device Name
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
Manufacturer
DAYSPRING MEDICAL, INC.
Date Cleared
1996-06-11
(89 days)
Product Code
FJI
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
DAYSPRING MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961026Device Name
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
Manufacturer
DAYSPRING MEDICAL, INC.
Date Cleared
1996-06-10
(88 days)
Product Code
FJI
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
DAYSPRING MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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