PR-84214

Basic Information

• Brand Name: PR-84214
• Primary DI: 00850005864233
• Version / Model: PR-84214
• Company Name: PATHEN MEDICAL LLC
• Labeler DUNS: 042928915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-24
• Public Version: 4
• Public Version Date: 2023-10-16
• Public Version Status: Update
• Public Device Record Key: 9528cde4-17ed-4b18-9883-ce6c4e0d3c32

Device Description

14g x 1 1/4” IV CATHETER PURSAFETY R

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: No
• 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
61650	Peripheral vascular/subcutaneous catheter	A sterile, dual-purpose, thin, flexible tube intended for: 1) insertion into the peripheral vasculature to enable short-term (< 30 days) intravascular access for blood sampling, blood pressure monitoring, fluid/medication administration and/or contrast media injection; and 2) administration of fluids/medication into subcutaneous tissue. It typically includes dedicated accessories to facilitate catheter introduction/function (e.g., connectors, injection ports, stylet, fixation wings, introduction needle). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850005864237	GS1		4	In Commercial Distribution
Package	10850005864230	GS1		50	In Commercial Distribution
Primary	00850005864233	GS1

Customer Contacts

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