5008X Fluid Sampling Accessory

GUDID 10840861102461

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis blood tubing set, single-use
Primary Device ID10840861102461
NIH Device Record Key826229ca-c891-42ee-b3f6-b22c1412c5f8
Commercial Distribution StatusIn Commercial Distribution
Brand Name5008X Fluid Sampling Accessory
Version Model Number04-9009-4
Company DUNS079732391
Company NameFresenius Medical Care Renal Therapies Group, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx
Phone1 (800) 323-5188
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861102464 [Primary]
GS110840861102461 [Package]
Contains: 00840861102464
Package: Case [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOCAccessories, Blood Circuit, Hemodialysis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-16
Device Publish Date2024-04-08

Devices Manufactured by Fresenius Medical Care Renal Therapies Group, LLC

00084086113014 - Acid connector cpl 10L jug2025-08-11 Acid connector cpl 10L jug
00084086113021 - Acid connector guide 1 Gal2025-08-11 Acid connector guide 1 Gal
10840861102515 - 5008X2025-08-11 5008X HD/HDF - Standard Blood Tubing Set
10840861102522 - 5008X2025-08-11 5008X HD/HDF - with Twister Blood Tubing Set
10840861102539 - 5008X2025-08-11 5008X HD/HDF - with CLiC Blood Tubing Set
10840861102553 - 5008X2025-08-11 5008X HD Pre-Flush – Standard Blood Tubing Set
10840861102560 - 5008X2025-08-11 5008X HD Pre-Flush – Twister Blood Tubing Set
10840861102607 - 5008X2025-08-11 5008X Venous Pressure Replacement Line with Transducer Protector
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.