L-Cath PICC Complete Kit

Basic Information

• Brand Name: L-Cath PICC Complete Kit
• Primary DI: 00886333209927
• Version / Model: 384518
• Catalog Number: 384518
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-07-24
• Public Version Status: Update
• Public Device Record Key: 5eba32b4-a129-46a3-833d-1af3599bf9b2

Device Description

L-Cath™ PICC S/L Complete Kit 28G (1.2F) x 25CM

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: 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: Yes
• 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
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333209921	GS1	Box	5	In Commercial Distribution
Primary	00886333209927	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			28ga (1.2F) x 25cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Away from Sunlight