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510(k) Data Aggregation
K Number
K231095Device Name
Tamper Evident Cap
Manufacturer
International Medical Industries, Inc.
Date Cleared
2024-09-04
(505 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
International Medical Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tamper Evident Caps (Sterile) are indicated for use as a sterile tamper evident cap for IV syringes.
Device Description
The International Medical Industries, Inc. Tamper Evident Cap consists of a polystyrene outer sleeve and bottom cover and a polypropylene tip cap held in place by a breakaway ring integrated into the sleeve. Evidence of access to the Luer lock cap is achieved by physically breaking the connection and removing the polystyrene outer sleeve exposing the Luer lock cap. Removal of the Luer Lock Cap is restricted by the presence of the sleeve. The restrictive sleeve and cap are available in multiple colors (cosmetic purposes only) in individual blister packs and trays of 10. The Luer Lock Caps are provided sterile to the end user. The sterilization method used is Ethylene Oxide.
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K Number
K201031Device Name
NRFit® Caps, Male and Female Neuraxial Tip Caps
Manufacturer
International Medical Industries, Inc.
Date Cleared
2020-12-16
(240 days)
Product Code
QEH
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
International Medical Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.
Device Description
The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.
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K Number
K190305Device Name
Additive Cap
Manufacturer
International Medical Industries, Inc.
Date Cleared
2019-04-30
(77 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
International Medical Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.
Device Description
The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.
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K Number
K182545Device Name
Tamper Evident Cap with Male Luer Lock
Manufacturer
International Medical Industries, Inc.
Date Cleared
2019-01-11
(116 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
International Medical Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.
Device Description
The Tamper Evident Cap with Male Luer Lock (MTEC) is a sterile, single use device which will be used to cover female Luer ports on medical devices and provide evidence of access. MTEC is provided in two packaging configurations; a 10-up tray and single unit blisters. Both configurations are offered in multiple colors and all the components used in the manufacture of MTEC are comprised of polystyrene and polypropylene resin.
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K Number
K170672Device Name
Tamper Evident Cap For use with ENFit Syringes
Manufacturer
International Medical Industries, Inc.
Date Cleared
2017-10-06
(214 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
International Medical Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.
Device Description
Tamper Evident Cap For use with ENFit® Syringes is a sterile, single use disposable device for use as a closure cap with evidence of access for Enteral Syringes with ENFit™ Connectors. Removal of the cap is achieved by removing a restrictive sleeve covering the ENFit™ Lock Cap. A damaged or missing restrictive sleeve indicates potential tampering. A non-sterile version of the device is also offered.
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