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 Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use
Primary Device ID10840861102379
NIH Device Record Key9bdd936c-06af-4b76-bd0f-d65848de17ee
Commercial Distribution StatusIn Commercial Distribution
Brand Name5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber
Version Model Number03-5100-7C
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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861102372 [Primary]
GS110840861102379 [Package]
Contains: 00840861102372
Package: Case [24 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

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10840861102775 - PureFlow2024-06-07 PureFlow RFP-400
10840861102782 - PureFlow2024-06-07 PureFlow RFP-407
10840861102799 - PureFlow2024-06-07 PureFlow RFP-401
10840861102362 - 5008X HDF Hemodialysis Blood Tubing Set2024-04-16
10840861102379 - 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber2024-04-16
10840861102379 - 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber2024-04-16
10840861102386 - 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw2024-04-16
10840861102461 - 5008X Fluid Sampling Accessory2024-04-16
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