Nipro Set Blood Tubing Set

Basic Information

• Brand Name: Nipro Set Blood Tubing Set
• Primary DI: 00383790008808
• Version / Model: A430/V912
• Catalog Number: BL+A430/V912
• Company Name: NIPRO MEDICAL CORPORATION
• Labeler DUNS: 797372554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-24
• Public Version: 1
• Public Version Date: 2020-08-03
• Public Version Status: New
• Public Device Record Key: 50145193-0bf3-48a5-b3c2-fb4ea782cdd9

Device Description

Blood Tubing Set for use with the SURDIAL DX Hemodialysis System

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: No
• 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
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40383790008806	GS1	case	24	In Commercial Distribution
Primary	00383790008808	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]