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510(k) Data Aggregation
K Number
K242820Device Name
Puritan PurSafe Plus Collection and Transport System
Manufacturer
Puritan Medical Products LLC
Date Cleared
2025-05-27
(251 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Puritan Medical Products LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan PurSafe Plus Collection and Transport System is an enclosed system intended for the collection, inactivation, and preservation of human upper respiratory specimens suspected of containing SARS-CoV-2. Puritan PurSafe Plus Collection and Transport System can be used for collection, transport, and storage of specimens at 2-4°C and 25-30°C. Specimens collected and stored in the PurSafe Plus Collection and Transport System are suitable for use with legally marketed molecular diagnostic devices.
Device Description
Puritan PurSafe Plus Collection and Transport System is comprised of a peel pouch containing a sterile polyester flock swab applicator for collecting clinical specimens and a polypropylene vial containing 1mL PurSafe Plus buffer. PurSafe Plus MK buffer ensures stability of Sars Cov-2 during sample transport/storage at refrigerated to ambient temperature (4-30°C) and is intended to inactivate Sars Cov-2.
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K Number
K162284Device Name
Puritan Fecal Opti-Swab Collection and Transport System
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2016-11-04
(81 days)
Product Code
JSM, JTW, JTX, LIO
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
Device Description
Puritan Fecal Opti-Swab Collection and Transport System is comprised of a sterile peel pouch containing a sterile polyester flock swab applicator for collecting clinical fecal and rectal specimens and a polypropylene vial containing 2 ml of Fecal Opti-Swab medium.
Fecal Opti-Swab medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability, chloride salts to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent that increases the viscosity of the medium. Sodium thioglycolate and L-cysteine provides an oxygen-reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
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K Number
K160082Device Name
Puritan Opti-Tranz Cary-Blair Collection and Transport System
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2016-07-29
(196 days)
Product Code
JSM, JTW, LIO
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
Device Description
Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium.
Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
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K Number
K142366Device Name
Puritan OptiTranz Liquid Stuart Collection and Transport System
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2015-01-09
(137 days)
Product Code
JSM, JTW, LIO
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.
Device Description
Puritan OptiTranz Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene vial containing 1 ml of Stuart liquid medium.
Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
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K Number
K131630Device Name
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2013-10-21
(139 days)
Product Code
LIO, JTW, JTX
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
Device Description
Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types.
Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
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K Number
K120846Device Name
TRANSPORT CULTURE MEDIUM DEVICE
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2012-06-08
(80 days)
Product Code
LIO, JTW, JTX
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
Device Description
Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
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K Number
K113249Device Name
TRANSPORT CULTURE MEDIUM DEVICE
Manufacturer
PURITAN MEDICAL PRODUCTS LLC
Date Cleared
2012-03-01
(119 days)
Product Code
JSM, LIO
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PURITAN MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.
Device Description
Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination.
Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations:
1ml UTM with ultrafine tip HydraFlock® Swab .
3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip
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