IV Start Kit w/Catheter, 18Ga

Basic Information

• Brand Name: IV Start Kit w/Catheter, 18Ga
• Primary DI: 00850018892896
• Version / Model: 020210
• Catalog Number: 020210
• Company Name: Altitude Technologies Inc.
• Labeler DUNS: 621904622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-08
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 84055a22-82be-46c3-9b9c-e141a13a5e88

Device Description

Catheter, intravascular, therapeutic, short-term - less than 30 days. Contains the items needed for starting and securing a saline lock for extremity venous cannulation.

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: Yes
• 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
LRS	I.V. Start Kit	General Hospital	880.5200	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
Primary	00850018892896	GS1

Customer Contacts

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