Fresenius HemaClip 04-9100-1

GUDID 20840861100822

Bloodline Connector Clip. For CombiSet Bloodlines only

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 20840861100822
• NIH Device Record Key: a2cc6024-da80-4e53-9360-07f8bd736511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresenius HemaClip
• Version Model Number: 04-9100-1
• Catalog Number: 04-9100-1
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, Inc.
• Device Count: 50
• 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: false
• 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	00840861100828 [Unit of Use]
GS1	10840861100825 [Primary]
GS1	20840861100822 [Package]; Contains: 10840861100825; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001873

FDA Product Code

• FJK: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2015-09-30

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