INTRAVENOUS INFUSION STARTER SET

Basic Information

• Brand Name: INTRAVENOUS INFUSION STARTER SET
• Primary DI: M68980100050
• Version / Model: 05
• Catalog Number: 80-100
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-18
• Public Version: 2
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: 0c9b7e93-0e24-45ca-ae21-9b331fae5a27

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 IV Administration Set 1 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea IV Catheter Dressing 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
18009	Intraosseous infusion kit	A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68980100050	HIBCC

Customer Contacts

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