SALINE LOCK KIT

Basic Information

• Brand Name: SALINE LOCK KIT
• Primary DI: M68980110050
• Version / Model: 05
• Catalog Number: 80-110
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-18
• Public Version: 5
• Public Version Date: 2024-11-01
• Public Version Status: Update
• Public Device Record Key: 1d8d6355-4d91-4b1b-8237-ad5003de7180
• Distribution End Date: 2023-12-31

Device Description

18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea Transparent Film Dressing 1 ea 2"x2" Gauze Pad (2 pack) 1 ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRS	I.V. Start Kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62389	Wound irrigation cannula	A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68980110050	HIBCC

Customer Contacts

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