NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE

Basic Information

• Brand Name: NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE
• Primary DI: 00383790000017
• Version / Model: 14GX1
• Catalog Number: FS+142530BCR
• Company Name: NIPRO MEDICAL CORPORATION
• Labeler DUNS: 797372554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-20
• Public Version: 3
• Public Version Date: 2018-12-20
• Public Version Status: Update
• Public Device Record Key: 8919a199-99aa-4a33-a8f6-05955a636de1

Device Description

14Gx1" Rotating Hub 11" Tubing

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
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	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	10383790000014	GS1	Carton	50	In Commercial Distribution
Primary	00383790000017	GS1
Package	40383790000015	GS1	Case	10	In Commercial Distribution