5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Renal Therapies Group, LLC

Identity

Trade Name: 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Model / Reference: 03-5150-2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861102389 FDA UDI
510(k) Number: K231534 FDA UDI
FDA Product Code: KOC FDA UDI
FJK FDA UDI
GMDN Term: Haemodialysis blood tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Haemodialysis blood tubing set, single-use

5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI…

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Also classified as Haemodialysis blood tubing set, single-use.

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NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION · Class II
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Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Lifemed Low Volume Tubing Set — Lifemed of California · Class II

Cleared under the same submission

K231534 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

FDA UDI 2bd51839-9004-4b74-970e-81a79e2b14a0 35 fields · synced May 31, 2026