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

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10840861102775 - PureFlow2024-06-07 PureFlow RFP-400
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