5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber

GUDID 10840861102379

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861102379
• NIH Device Record Key: 9bdd936c-06af-4b76-bd0f-d65848de17ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber
• Version Model Number: 03-5100-7C
• Company DUNS: 079732391
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102372 [Primary]
GS1	10840861102379 [Package]; Contains: 00840861102372; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231534

FDA Product Code

• KOC: Accessories, Blood Circuit, Hemodialysis

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-16
• Device Publish Date: 2024-04-08

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