Pre-gelled bag, folded, 2000 ml

Basic Information

• Brand Name: Pre-gelled bag, folded, 2000 ml
• Primary DI: 06418685047014
• Version / Model: 570567-0
• Company Name: Serres Oy
• Labeler DUNS: 401738638
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 22
• Record Status: Published
• Publish Date: 2018-02-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 05efd025-7383-4dac-b888-54ee7523f284

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	Bottle, Collection, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44942	Suction system canister liner	A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06418685047021	GS1	Delivery box	6	In Commercial Distribution
Primary	06418685047014	GS1
Unit of Use	06418685062567	GS1