NovaLine

FDA UDI

Class II (US FDA UDI)

by Bain Medical Equipment (Guangzhou) Co., Ltd.

Identity

Trade Name: NovaLine FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Model / Reference: BL 42 FDA UDI

Identifiers

Primary DI / UDI-DI: 06948082709777 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

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

NovaLine by Bain Medical Equipment (Guangzhou) 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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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: Bain Medical Equipment (Guangzhou) Co., Ltd.

Sources (1)

FDA UDI c17ff785-7492-4466-8755-371f82796ba1 32 fields · synced Jun 8, 2026