Search Results
Found 2 results
510(k) Data Aggregation
K Number
K110262Device Name
SHARPS CONTAINER
Manufacturer
Date Cleared
2011-04-05
(67 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
NOBLE MARKETING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.
Device Description
The Noble Sharps Container are intended to be used at healthcare facilities, including nursing stations, medication carts, laboratories, emergency rooms, treatment rooms, and other small quantity waste generators for the safe disposal of hazardous sharps.
The Nobles Sharps Container is a single use device designed for the safe disposal of hazardous sharps. It is designed with 4-chambers, each chamber will hold one sharps. After each chamber is filled with a sharp, a locking lid is closed by pressing downward, thus permanently sealing the sharps inside the container. All materials including the bottom, sides, and locking lid are manufactured using PP7726 (polypropylene) the same material used in the predicate device, the GongDong disposable sharps container cleared under K082042. The size of the Noble Sharps Container is 6 7/16" in height, 4 15/16" in width and 2 7/16" in depth.
Ask a Question
Ask a specific question about this device
K Number
K101380Device Name
RXPEAKFLOW
Manufacturer
Date Cleared
2010-09-13
(119 days)
Product Code
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
NOBLE MARKETING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
Device Description
The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
Ask a Question
Ask a specific question about this device
Page 1 of 1