Blood Tubing Lines For Hemodialysis

FDA UDI

Class II (US FDA UDI)

by Nikkiso Co., Ltd.

Identity

Trade Name: BLOOD TUBING LINES FOR HEMODIALYSIS FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Device Name: The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System. FDA UDI
Model / Reference: AV06C-P FDA UDI
Description: The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987671201102 FDA UDI
FDA Product Code: KOC 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

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Haemodialysis blood tubing set, single-use

Blood Tubing Lines For Hemodialysis by Nikkiso Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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5008X — Fresenius Medical Care Renal Therapies Group, LLC · 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

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: Nikkiso Co., Ltd.

Sources (1)

FDA UDI 0d919b91-fdc3-4325-8d7f-e71b28239142 35 fields · synced May 30, 2026