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510(k) Data Aggregation
K Number
K231484Device Name
PureWay 1.4 Quart Sharps Collector
Manufacturer
PureWay Compliance Inc.
Date Cleared
2023-09-14
(114 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.
Device Description
The PureWay Sharps Collector is injection molded with High Density Polyethylene plastic (HDPE). Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white and blue with white text and a black biohazard symbol is printed on a red background. The container is made of two parts, (Base and Lid) that form a single unit. The red colored base is conical shaped, and the lid is a clamshell design snapped in place for a tight seal when the container is full. The device is a non-sterile, single use, disposable infectious waste container and is designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container is conical which allows for one hand disposal of sharps and a clamshell lid for means of closure.
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K Number
K222906Device Name
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
Manufacturer
Ningbo Maxcon Medical Technology Co., Ltd.
Date Cleared
2023-06-16
(266 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
Device Description
Maxcon Reusable Sharps Container is of injection molded high density polyethylene plastic, and designed for a multiple-use of 250 cycles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be non-sterile, puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line. The container body is in the color of red, while the container lid is in the color of black. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The black lid is used to slide across the container top. When in use, move the lid to show an opening with a size depending on the sharps waste to be dropped, and drop sharps waste into the container safely and effectively by gravitational force, allows easy disposal of sharps. After the sharps is deposited, slide the lid closed along the groove to recover the container body for temporary closure. When the content reaching to the fill line, use a 6" cable tie to lock together the lid and container body for final closure. The container is not for use in area with unsupervised patient access.
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K Number
K222905Device Name
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
Manufacturer
Ningbo Maxcon Medical Technology Co., Ltd.
Date Cleared
2023-06-01
(251 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Device Description
Maxcon Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of polypropylene , the same as that of the comparable predicate devices. Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line. The cover base and the lid (closure) come pre-assembled with the body not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
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K Number
K213274Device Name
Qlicksmart BladeFlask UNIVERSAL
Manufacturer
Qlicksmart Pty Ltd.
Date Cleared
2022-06-22
(265 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include:
- Swann Morton sizes 3. 4. 5. 6. 7. 8. and 9
- Lawton size 4
- Martin sizes 3, 4, and 7
- Aesculap sizes 3. 4. 6. and 7
- Sayco sizes 3, 4, and 5
- Smic sizes 3 and 4
- Nopa sizes 3 and 4
- AB Stainless size 4
- Lance sizes 3 and 4
- Pro-Med sizes 3 and 4
- Paragon sizes 3 and 4
- Rocket size 5
- Conqueror size 3
- Feather sizes 3. 4. and 7
- LRI sizes 3 and 4
- Generic handle size 4
- L-dent
- Medesy size 5
- Jakobi size 4
- CS size 5
- Helmut Zepf
Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:
- Beaver type handles
- Disposable handles
Device Description
The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The Qlicksmart BladeFlask PLUS removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the Qlicksmart BladeFlask PLUS. The handle is intended to be used to dispose the entire container as hazardous waste when full (100 removed blades and shut-off system is activated) and the device is not intended to be reprocessed.
The Qlicksmart BladeFlask PLUS combines a hard plastic sharps container with an internal blade remover mechanism made of hard plastic and hardened steel parts.
It is approximately (13.5 cm) tall by (9.1 cm) wide by (12.3 cm) deep. It weighs less than 250gm per unit when empty. It is red in color. It is labelled as shown on the samples provided with this application.
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K Number
K211890Device Name
Promisemed Sharps container
Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.
Date Cleared
2021-11-17
(149 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.
Device Description
The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers.
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K Number
K211464Device Name
Nitta M&T Safety Box
Manufacturer
Nitta M&T (Thailand) Co., Ltd.
Date Cleared
2021-09-14
(126 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
Device Description
Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.
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K Number
K203305Device Name
Tiger Reusable Sharps Container
Manufacturer
International Marketing Specialists Inc.
Date Cleared
2021-08-06
(270 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Device Description
Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture-resistant, leak-resistant on the sides and bottom, impact-resistant, closable, and stable.
The base is made from a high-strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line.
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K Number
K201523Device Name
Sharps container
Manufacturer
Zhejiang Gongdong Medical Technology Co., Ltd
Date Cleared
2020-11-12
(157 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Device Description
Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.
The Sharps Container constructed of polypropylene plastic. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable, and stable.
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K Number
K190240Device Name
Tiger Sharps Containers
Manufacturer
International Marketing Specialists Inc.
Date Cleared
2019-05-31
(114 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Product Code :
MMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers 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 in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only be used with appropriate mounting accessories.
Device Description
Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the level line on the product identification label.
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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?
Product Code :
MMK
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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