Nipro SafeTouch TULIP Safety Fistula Needle

Basic Information

• Brand Name: Nipro SafeTouch TULIP Safety Fistula Needle
• Primary DI: 00383790001779
• Version / Model: FT+152540BC
• Company Name: NIPRO MEDICAL CORPORATION
• Labeler DUNS: 797372554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: 3b446a26-790b-464f-92de-c120cc6a63b6

Device Description

SafeTouch Tulip Safety AVF (15Gx1") 16" tube, fixed hub

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
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10383790001776	GS1	box	50	In Commercial Distribution
Primary	00383790001779	GS1
Package	40383790001777	GS1	case	6	In Commercial Distribution

Customer Contacts

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