Sharps 1.2 Gallon

GUDID 00853022008109

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.

PUREWAY COMPLIANCE

Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container

• Primary Device ID: 00853022008109
• NIH Device Record Key: a210834d-5a23-4b7c-8468-27b26c0b0386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sharps
• Version Model Number: 1.2 Gallon
• Catalog Number: 1.2 Gallon
• Company DUNS: 064845056
• Company Name: PUREWAY COMPLIANCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon
• Total Volume: 1.2 Gallon

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853022008109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151249

FDA Product Code

• MMK: Container, Sharps

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-13
• Device Publish Date: 2018-01-15

On-Brand Devices [Sharps]

• 00853022008123: Sharps container: A device designed as a container to allow the safe deposit and collection of b
• 00853022008116: Sharps container: A device designed as a container to allow the safe deposit and collection of b
• 00853022008109: Sharps container: A device designed as a container to allow the safe deposit and collection of b