CAREline 0450007

GUDID 10840861102072

Dialyzer Holder Lock Sleeve

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis system dialyser holder

• Primary Device ID: 10840861102072
• NIH Device Record Key: b8be9e90-d20f-4f01-917b-5626d6cc4c6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREline
• Version Model Number: 0450007
• Catalog Number: 0450007
• Company DUNS: 079732391
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102075 [Primary]
GS1	10840861102072 [Package]; Contains: 00840861102075; Package: null [12 Units]; In Commercial Distribution

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-22
• Device Publish Date: 2018-05-22

On-Brand Devices [CAREline]

• 10840861100405: 0342006
• 10840861102072: Dialyzer Holder Lock Sleeve