Alaris

Basic Information

• Brand Name: Alaris
• Primary DI: 50885403234420
• Version / Model: 10800177
• Catalog Number: 10800177
• Company Name: CAREFUSION 303, INC.
• Labeler DUNS: 360624720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: d60de9ac-499e-43a0-ac34-2113b22fc603

Device Description

Alaris PCEA Administration 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
41477	Patient-controlled analgesia electric infusion pump administration set	A collection of sterile devices that typically consists of a reservoir (e.g., a syringe or plastic pouch), plastic tubing, a check valve, and Luer connectors, designed for the controlled intravenous (IV) administration of opioid pain medication using an electrically-powered, patient-controlled analgesia (PCA) infusion pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50885403234420	GS1
Unit of Use	10885403234422	GS1

Customer Contacts

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

Storage Conditions

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