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510(k) Data Aggregation
K Number
K972448Device Name
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
Manufacturer
COPAN ITALIA SPA
Date Cleared
1997-08-20
(51 days)
Product Code
JSL
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
COPAN ITALIA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Copan Venturi Transystem Amies Medium Without Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium Without Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.
Device Description
The Copan Venturi Transystem Amies Medium Without Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium Without Charcoal and are offered in six models. The only difference in the six models is the type of applicator used for the collection of the bacteriological sample. The applicator shafts vary for facilitation of the collection of the specimen from various sites of the patient. The six types of Copan Venturi Transystem Amies Medium Without Charcoal products are:
- Product Code 108C with plastic applicator .
- Product Code 134C with two plastic applicators .
- Product Code 110C with regular aluminum applicator •
- Product Code 124C with soft aluminum applicator .
- Product Code 128C with slim paper applicator .
- . Product Code 190C with flexible twisted wire applicator
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K Number
K972449Device Name
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
Manufacturer
COPAN ITALIA SPA
Date Cleared
1997-08-20
(51 days)
Product Code
JSL
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
COPAN ITALIA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, singleuse specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.
Device Description
The Copan Venturi Transystem Amies Medium With Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium With Charcoal and are offered in six models. The only difference in the six models is the type of applicator used for the collection of the bacteriological sample. The applicator shafts vary for facilitation of the collection of the specimen from various sites of the patient. The six types of Copan Venturi Transystem Amies Medium With Charcoal products are:
- Product Code 114C with plastic applicator .
- Product Code 136C with two plastic applicators .
- Product Code 116C with regular aluminum applicator .
- Product Code 125C with soft aluminum applicator .
- Product Code 129C with slim paper applicator .
- Product Code 192C with flexible twisted wire applicator .
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