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510(k) Data Aggregation
K Number
K083129Device Name
SHARPS COMPLIANCE CONTAINER
Manufacturer
SHARPS COMPLIANCE, INC.
Date Cleared
2008-12-15
(54 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHARPS COMPLIANCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.
Device Description
The Sharps Compliance Container is a sharps container (disposable infectious waste container) in 1 gallon, 2 gallon and 3 gallon sizes designed to meet Occupational Safety and Health Administration ("OSHA") regulations on bloodborne pathogens (29 C.F.R. 1910.1030).
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K Number
K073577Device Name
SHARPS TRANSPORT TUBE, MODEL 50035
Manufacturer
SHARPS COMPLIANCE, INC.
Date Cleared
2008-06-23
(186 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHARPS COMPLIANCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.
Device Description
Sharps Compliance Sharps Transport Tube Model 50035
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