K-Systems

Basic Information

• Brand Name: K-Systems
• Primary DI: 00888937024005
• Version / Model: 6.131.912.121
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-12
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 364b5496-36db-4eb8-a212-9d82b00154da

Device Description

L126 DUAL, RI Witness

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
PUB	Accessory, Assisted Reproduction, Exempt	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40522	Laminar airflow hood	A ventilated laboratory enclosure designed to prevent airborne biological contamination of laboratory specimens contained within, and personnel handling the specimen, by creating a barrier with a forced flow of uniform-velocity and parallel-direction air. It is typically a plastic/metallic cabinet-like structure with an open front for product handling and a sash to regulate the opening. Air is typically drawn from the environment into the system by negative pressure created by a line-powered blower; air particles and liquid droplets are removed usually using high-efficiency particulate air (HEPA) filters. Contaminated air is usually exhausted to the outside; also known as an LAF bench.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888937024005	GS1