NovaLine

Basic Information

• Brand Name: NovaLine
• Primary DI: 06948082770036
• Version / Model: 956007
• Company Name: Bain Medical Equipment (Guangzhou) Co., Ltd.
• Labeler DUNS: 526972767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-31
• Public Version: 2
• Public Version Date: 2025-08-07
• Public Version Status: Update
• Public Device Record Key: bc742baf-5a73-45b9-9142-8f2a157afb04

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32109	Haemodialysis system transducer protector	A device designed to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent transfer of by viruses, bacteria, and particulate matter, while preventing the flow of fluids, to the pressure monitor. It may feature tubing and a male Luer lock designed to facilitate replacement of a contaminated transducer protector via a secondary connection on the pressure monitor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16948082770033	GS1		60	In Commercial Distribution
Primary	06948082770036	GS1
Package	26948082770030	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K240164	000