5008X Fluid Sampling Accessory

Basic Information

• Brand Name: 5008X Fluid Sampling Accessory
• Primary DI: 00840861102464
• Version / Model: 04-9009-4
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• Labeler DUNS: 079732391
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-08
• Public Version: 4
• Public Version Date: 2025-12-22
• Public Version Status: Update
• Public Device Record Key: 826229ca-c891-42ee-b3f6-b22c1412c5f8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67201	Haemodialysis dialysate sampling set	A collection of noninvasive devices which includes tubing, connectors, clamps and a collection bag intended to be used for the sampling of dialysate solution from a haemodialyser, typically for subsequent microbiology and endotoxin laboratory testing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840861102461	GS1	Case	15	In Commercial Distribution
Primary	00840861102464	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Protect from moisture, freezing and excessive heat.