Safe-Lock®

GUDID 10840861100818

APD Luer-Lock Adapter

Fresenius Medical Care Holdings, Inc.

Peritoneal dialysis system tubing set

• Primary Device ID: 10840861100818
• NIH Device Record Key: 100f5fe3-bdef-47ea-b3bf-a756bed74208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Lock®
• Version Model Number: 050-95018
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100811 [Primary]
GS1	10840861100818 [Package]; Contains: 00840861100811; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124024

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-02

On-Brand Devices [Safe-Lock®]

• 10840861100818: APD Luer-Lock Adapter
• 00840861100705: Safe-Lock® Catheter Adapter Co-Pack Type II
• 10840861100665: Safe-Lock® Universal Connector
• 10840861100658: Safe-Lock® Catheter Adapter Sealing Cap