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Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System, with Modified Stuart's, Modified Amies, and Cary-Blair Transport Media is intended for use as a disposable, sterile culture Collection device for use in the collection, preservation, and transportation of microbiological specimens. Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System is intended to be used for the collection, preservation, and transport of bacteriological specimens to the laboratory for evaluation. The media is intended to preserve the integrity of the specimen as well as minimize overgrowth of other organisms during transport.

Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System, available with Modified Stuart's, Modified Amies, and Cary-Blair Transport Media, is substantially equivalent to Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1), CULTURE-PAK ™ Collection and Transport System, Modified Amies Transport Media, K964637, and CULTURE-PAK™ Collection and Transport System, Clinical Transport Media (K970597). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts: - The top plastic part of the single swab device holds 0.4 mL of transport media . and a plastic shaft, Rayon® tipped swab. The top plastic part of the dual swab device holds 0.6 mL of transport media and two plastic shaft, Rayon® tipped swabs , and the top plastic part of the device with the Rayon® Mini-Tip swab holds 0.3 mL of transport media. The aluminum shaft, Rayon® Mini-Tip swab is for collection of either male urethral or nasopharyngeal specimens. - The bottom plastic part of the device protects the swab(s) { hereafter referred . to as: Culture Collection device ) and fits tightly into the top plastic part. The SNAP SWAB™ Culture Collection and Transport System is packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for all configurations. The two plastic parts are pulled apart, exposing the swab(s). After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the Culture Collection device moist for up to 72 hours at room temperature. (1) The release of media from the cap through the hollow shaft of the SNAP SWAB™ is accomplished by breaking the swab shaft within the cap rather than breaking the plastic snap valve. The action required for breaking the swab and the snap valve are identical. Once the shaft is broken, the media flow through the shaft is identical to the CULTURE-PAK™ device. (2) The SNAP SWAB™ culture tube is individually labeled and is packaged 50 to a labeled foil pouch. Like the CULTURE-PAK™, the SNAP SWAB™ sealed hollow shaft is seated in the plug that holds the media in the top part of the device. The top is bent 45 ° to break the shaft allowing the media to flow through the exposed open shaft orifice into the bottom of the tube. The SNAP SWAB™ Culture Collection and Transport System, will also be available with two plastic shaft, Rayon® tipped swabs, and with an aluminum shaft Rayon® Mini-Tip ( Universal ) rayon swab.

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Clinical Transport Media, (Cary-Blair Transport Media Option) is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Devices are composed of two plastic parts: - The top plastic part holds 0.4 mL of clinical transport media and a plastic . shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens. - The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ Collection and Transport System is packaged sterile. - Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System. Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts: - . The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens; or a CytoSoft™ cytology brush. - The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ and the Culture Collection and Transport Device are packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices. The methods for use are similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 48 hours at room temperature. The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45 ° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.