CombiSet SMARTECH

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Renal Therapies Group, LLC

Identity

Trade Name: CombiSet SMARTECH FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Model / Reference: 03-2742-9C FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861102259 FDA UDI
510(k) Number: K201207 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

CombiSet SMARTECH by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

10" Dialysis Tubing Extensions (Pair) — Cardio Med Supplies, Inc. · Class II
CombiSet — Fresenius Medical Care Holdings, Inc. · Class II
Hemodialysis Bloodlines — B. BRAUN MEDICAL INC. · Class II
SAMI Hemofiltration Cassette — Dialco Medical Inc · Class II
NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION · Class II
Nipro Set Blood Tubing Set — NIPRO MEDICAL CORPORATION · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Lifemed Low Volume Tubing Set — Lifemed of California · Class II

Cleared under the same submission

K201207 also covers:

CombiSet SMARTECH — Fresenius Medical Care Renal Therapies Group, LLC

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 d356f3bd-386a-4ad7-8385-83323af908ab 35 fields · synced May 30, 2026