NI-FLEX

Basic Information

• Brand Name: NI-FLEX
• Primary DI: 08033003344965
• Version / Model: NI-FLEX
• Catalog Number: NIPJ 35150-H
• Company Name: H.S. HOSPITAL SERVICE SPA
• Labeler DUNS: 428898555
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-01
• Public Version: 2
• Public Version Date: 2024-03-20
• Public Version Status: Update
• Public Device Record Key: 1c39f817-f14d-447a-8847-4b6111030221

Device Description

FILO GUIDA 0.035"X1500MM

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
KGZ	Accessories, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62391	Non-vascular catheter introduction set	A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28033003344969	GS1		5	In Commercial Distribution
Primary	08033003344965	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1500	Millimeter
Outer Diameter	0.035	Inch