APmedical

Basic Information

• Brand Name: APmedical
• Primary DI: 08013183101930
• Version / Model: FGSC30DYC001 SC30DY
• Company Name: ABM ITALIA SPA
• Labeler DUNS: 338493631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-10
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 50056995-d334-41fa-871c-831c278caefa

Device Description

(8 Gal CHEMO USA YELL Disposable Container w/Port/Duo Lid) Single EA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Manufacturing Date: Yes
• 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	08013183101930	GS1

Premarket Submissions

Submission Number	Supplement Number
K071517	000