Alaris, SmartSite

Basic Information

• Brand Name: Alaris, SmartSite
• Primary DI: 20885403234887
• Version / Model: 20053E
• Catalog Number: 20053E
• Company Name: CAREFUSION 303, INC.
• Labeler DUNS: 360624720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-04-27
• Public Version Status: Update
• Public Device Record Key: a688aa56-7a03-4d13-9c4a-8846cc1b2573

Device Description

Alaris SmartSite Extension Set

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403234888	GS1	Case	4	In Commercial Distribution
Primary	20885403234887	GS1
Unit of Use	10885403234880	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 125 Degrees Fahrenheit