stay.safe®

GUDID 10840861100795

stay.safe® Catheter Extension Set with Luer-Lock, 18 inch

Fresenius Medical Care Holdings, Inc.

Peritoneal dialysis system tubing set

• Primary Device ID: 10840861100795
• NIH Device Record Key: 6e327276-d137-48f9-bc6b-b31c6004dae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: stay.safe®
• Version Model Number: 050-95005
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100798 [Primary]
GS1	10840861100795 [Package]; Contains: 00840861100798; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173593

FDA Product Code

• KDJ: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-19
• Device Publish Date: 2015-10-02

On-Brand Devices [stay.safe®]

• 10840861100771: stay.safe® to Luer-lock Adapter, 4 inch
• 10840861100801: stay.safe® Catheter Extension Set with Luer-Lock, 6 inch
• 10840861100795: stay.safe® Catheter Extension Set with Luer-Lock, 18 inch
• 10840861100788: stay.safe® Catheter Extension Set with Luer-Lock, 12 inch
• 10840861100764: stay.safe® Catheter Extension Set with Safe-Lock®, 12 inch
• 10840861100696: Multiple Tubing Segment (MTS) Set with stay.safe® PIN Connectors
• 10840861100580: stay.safe® Drain Set