Acid connector guide 1 Gal

GUDID 00084086113021

Acid connector guide 1 Gal

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis system, institutional

• Primary Device ID: 00084086113021
• NIH Device Record Key: 0ec6a0b1-6bd8-4ba1-a6c2-470f7303c94d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acid connector guide 1 Gal
• Version Model Number: F50044953
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00084086113021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243505

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

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: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by Fresenius Medical Care Renal Therapies Group, LLC

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• 00084086113021 - Acid connector guide 1 Gal: 2025-08-11Acid connector guide 1 Gal
• 00084086113021 - Acid connector guide 1 Gal: 2025-08-11 Acid connector guide 1 Gal
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• 10840861102539 - 5008X: 2025-08-11 5008X HD/HDF - with CLiC Blood Tubing Set
• 10840861102553 - 5008X: 2025-08-11 5008X HD Pre-Flush – Standard Blood Tubing Set
• 10840861102560 - 5008X: 2025-08-11 5008X HD Pre-Flush – Twister Blood Tubing Set
• 10840861102607 - 5008X: 2025-08-11 5008X Venous Pressure Replacement Line with Transducer Protector