Search Results
Found 1 results
510(k) Data Aggregation
K Number
K132792Device Name
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
Manufacturer
Date Cleared
2014-01-31
(147 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
DANIELS SHARPSMART, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Overthe-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles.
Device Description
Ecoship Disposable Sharps Containers are single-use sharps containers designed for point-first disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes. The containers are intended to be used in supervised areas of human and veterinary healthcare facilities. These areas may include nursing stations, laboratories, dental offices, physician offices, clinics, emergency rooms, surgical rooms, treatment rooms, research facilities, veterinarian practices and other small quantity waste generators. The devices are also intended to be used in healthcare facility mail-back programs and in home healthcare by clinical staff.
Two Ecoship Disposable Sharps Container models are described in this submission:
- D2-ES is 2 liters with fill capacity of 1.5 liters .
- o Tare: 192 grams (6.77 oz)
- o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm
- D4-ES is 4 liters with fill capacity of 3 liters .
- o Tare: 304 grams (10.72 oz)
- Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o
Ask a Question
Ask a specific question about this device
Page 1 of 1