stay•safe® organizer

Basic Information

• Brand Name: stay•safe® organizer
• Primary DI: 00840861102310
• Version / Model: 030-10807
• 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: 2019-05-09
• Public Version: 2
• Public Version Date: 2019-10-21
• Public Version Status: Update
• Public Device Record Key: c02e68df-7539-4995-9d59-848acc92f1e0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64369	Peritoneal dialysis manifold, single-use	A noninvasive device designed to provide multiple connections for the various tubes used during peritoneal dialysis (patient, dialysate, waste) so that the patient or healthcare provider can conveniently switch the connection between different tubes during the sequence of the procedure. It consists of multiple channels for fixing tubes in place and a tap, or other switching component, to isolate the connection between the various tubes. It may have components for holding the device in place on surfaces (e.g., suction cups). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840861102317	GS1	Case	40	In Commercial Distribution
Primary	00840861102310	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173718	000