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510(k) Data Aggregation
K Number
K182235Device Name
OnSite Waste Sharps Container
Manufacturer
Bluestone Medical, Inc.
Date Cleared
2019-05-20
(276 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Bluestone Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
Device Description
The OnSite Waste Sharps Container OWTSH-I is constructed using tinplate steel base with a Nylon and polypropylene restrictive lid system. The OnSite Waste Sharps Container OWTSH-I measures 10 1/2" wide x 4 3/4" deep, and tapers to a dimension of 9" wide x 3 1/8 deep. The height of the container is 8 1/4" in height. The OnSite Waste Sharps Container OWTSH-I is equipped with a locking lid that once closed, prevents anyone from opening it either before or after processing. Labels are on a red background with printed in black text and a bio-hazzard symbol. Labels are adhered to the container at the time of manufacture with the fill line warning printed on the label There is no feature to bend, break, or shear needle, includes blunting of needle in container.
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