CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 20192253008347
• Version / Model: 500500
• Catalog Number: 500500
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 4
• Public Version Date: 2021-09-30
• Public Version Status: Update
• Public Device Record Key: 24a6ace8-c7d2-4465-91b6-2b7eb920eba7
• Distribution End Date: 2021-09-30

Device Description

FILAC 3000 PROBE COVERS 500

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: 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
Package	50192253008348	GS1	CASE	25	Not in Commercial Distribution	2021-09-29
Primary	20192253008347	GS1
Unit of Use	10192253008340	GS1