Alaris

Basic Information

• Brand Name: Alaris
• Primary DI: 10885403812002
• Version / Model: 8120
• Company Name: CAREFUSION 303, INC.
• Labeler DUNS: 360624720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-08
• Public Version: 4
• Public Version Date: 2022-02-28
• Public Version Status: Update
• Public Device Record Key: c08e86ac-efef-49be-9056-37465afab5fc

Device Description

Alaris PCA Module

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEA	Pump, infusion, pca	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35932	Patient-controlled analgesia infusion pump	A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885403812002	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043299	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg
• Type: Storage Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit