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Found 4 results
510(k) Data Aggregation
K Number
K021941Device Name
SAMPLOK LUER KIT
Manufacturer
ITL CORPORATION, PTY LTD.
Date Cleared
2002-07-02
(19 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
ITL CORPORATION, PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.
Device Description
Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.
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K Number
K021017Device Name
LEESPEC DISPOSABLE VAGINAL SPECULUM
Manufacturer
ITL CORPORATION, PTY LTD.
Date Cleared
2002-06-19
(82 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ITL CORPORATION, PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.
Device Description
The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
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K Number
K000777Device Name
SAMPLOK
Manufacturer
ITL CORPORATION, PTY LTD.
Date Cleared
2000-04-11
(33 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
ITL CORPORATION, PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991404Device Name
PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
Manufacturer
ITL CORPORATION, PTY LTD.
Date Cleared
1999-05-14
(22 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ITL CORPORATION, PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AV Fistula Needle Protector (AVFNP) is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures.
Device Description
The AV Fistula Needle Protector (AVFNP) is a disposable, single-use, non-sterile needle protector, which is used as an aid in preventing accidental needle stick injuries upon completion of hemodialysis and apheresis procedures. The design of the AVFNP is compatible with currently marketed AV Fistula needle sets produced by most major manufacturers.
The hinged assembly allows the AVFNP to be included on AV Fistula needle sets at the time of manufacture or during a hemodialysis or apheresis procedure (i.e., before needle insertion or just prior to withdrawal). Once the AVFNP is clipped over the tubing, it can be engaged at any time by moving the AVFNP down the tubing to rest behind the butterfly wings of the AV Fistula needle. Prior to withdrawal of the needle, the AVFNP should be held securely between the index finger and thumb while the other hand pulls the tubing and needle assembly into the AVFNP. This position shields the point of the needle. A lock, an additional safety feature, can be activated once the needle has been shielded by pressing the top and bottom of the AVFNP together. This lock restricts further access to the needlepoint and contains any blood that may drop from the needle. An audible click can be heard when the lock is activated.
The AVFNP can be operated with either hand and leaves the other hand free to apply pressure to the puncture point and/or stabilize the AVFNP while withdrawing the needle. The AVFNP can be stabilized by holding, between the index finger and thumb, either the ribbed area on the front (e.g., when health care professional applies pressure to the puncture site during withdrawal of the needle) or the thumb rest on the back (e.g., when patient applies pressure to the puncture site during withdrawal of the needle).
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