Sharps

Basic Information

• Brand Name: Sharps
• Primary DI: 00853022008116
• Version / Model: 2 gallon
• Catalog Number: 2 gallon
• Company Name: PUREWAY COMPLIANCE
• Labeler DUNS: 064845056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-15
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: eb5a8f7b-2245-4ec5-bc46-6f3b189e119a

Device Description

Sharps container: A device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMK	Container, Sharps	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35429	Sharps container	A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853022008116	GS1

Premarket Submissions

Submission Number	Supplement Number
K151249	000

Device Sizes

Type	Value	Unit	Text
Total Volume	2.0	Gallon