Blood Tube Set

FDA UDI

Class II (US FDA UDI)

by Quanta Dialysis Technologies, Ltd.

Identity

Trade Name: Blood Tube Set FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Device Name: Quanta Dialysis System Blood Tube Set FDA UDI
Model / Reference: SC-14358 FDA UDI
Description: Quanta Dialysis System Blood Tube Set FDA UDI

Identifiers

Primary DI / UDI-DI: 05060497260016 FDA UDI
FDA Product Code: 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

Yes

FDA UDI

Category: Haemodialysis blood tubing set, single-use

Blood Tube Set by Quanta Dialysis Technologies, 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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CombiSet — Fresenius Medical Care Holdings, Inc. · Class II
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SAMI Hemofiltration Cassette — Dialco Medical Inc · Class II
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: Quanta Dialysis Technologies, Ltd.

Sources (1)

FDA UDI 2d2bc557-58b1-4f00-b002-2b7cec56c36b 33 fields · synced May 30, 2026