Cycler Drain Bag Set

Basic Information

• Brand Name: Cycler Drain Bag Set
• Primary DI: 00840861102037
• Version / Model: 026-20226A
• Catalog Number: 026-20226A
• Company Name: Fresenius Medical Care Holdings, Inc.
• Labeler DUNS: 958291411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-11
• Public Version: 3
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 47336087-4f6f-48ee-b110-2edef872ab2a

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58848	Extracorporeal circuit waste bag	A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840861102037	GS1
Package	10840861102034	GS1		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173363	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at Room Temperature. Protect from excessive heat and freezing