Alaris, Turbo Temp, Turbo Temp Plus

Basic Information

• Brand Name: Alaris, Turbo Temp, Turbo Temp Plus
• Primary DI: 50885403229907
• Version / Model: P850A
• Catalog Number: P850A
• Company Name: CAREFUSION 303, INC.
• Labeler DUNS: 360624720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2021-11-29
• Public Version Status: Update
• Public Device Record Key: a17f402e-d39f-4799-b141-060bfcb8e5f5

Device Description

Alaris Tri-Site, Turbo Temp and Turbo Temp Plus II Probe Covers

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50885403229907	GS1
Unit of Use	10885403229909	GS1

Customer Contacts

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

Storage Conditions

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