CombiSet Twister 03-2794-0

GUDID 10840861100313

Pre-pump, 8.0 mm, with Twister® Reverse Access Flow Device

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861100313
• NIH Device Record Key: 3dfa9781-f532-40b1-8770-a70c8ada49d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CombiSet Twister
• Version Model Number: 03-2794-0
• Catalog Number: 03-2794-0
• 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

Device Dimensions

• Total Volume: 142 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100316 [Primary]
GS1	10840861100313 [Package]; Contains: 00840861100316; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022536

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

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: 2019-06-07
• Device Publish Date: 2015-09-24

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