Direct IV Solutions - IV Start Kit

Basic Information

• Brand Name: Direct IV Solutions - IV Start Kit
• Primary DI: 00851491007500
• Version / Model: 2534-20G
• Catalog Number: 2534-20G
• Company Name: Lynn Medical Instrument Co.
• Labeler DUNS: 058810771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-23
• Public Version: 1
• Public Version Date: 2020-05-01
• Public Version Status: New
• Public Device Record Key: 24d82bb0-07fa-456c-9fae-31a21090811c

Device Description

IV Starter Kit - BD 20G Insyte Catheter, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OJS	Tourniquet Kit	General, Plastic Surgery	878.5900	1
LRS	I.V. Start Kit	General Hospital	880.5200	2
OFN	Winged Intravenous Catheterization Kit	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851491007507	GS1	CS	100	In Commercial Distribution
Primary	00851491007500	GS1
Package	40851491007508	GS1	CS	50	In Commercial Distribution

Customer Contacts

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