Alaris

Basic Information

• Brand Name: Alaris
• Primary DI: 10885403860003
• Version / Model: 8600
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 19c3a1f4-b07c-4f25-97c5-1cec52b3c6cc

Device Description

Alaris Auto-ID 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
FRN	Pump, infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37035	Barcode reader	A device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885403860003	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041241	000

Storage Conditions

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