Genius

Basic Information

• Brand Name: Genius
• Primary DI: 30884521689293
• Version / Model: 303030
• Catalog Number: 303030
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2018-07-04
• Public Version: 4
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 4ba33079-a63b-41fe-b52c-797139a354dd
• Distribution End Date: 2023-07-01

Device Description

Tympanic 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: 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	20884521689296	GS1	CASE	2112	Not in Commercial Distribution	2023-07-01
Primary	30884521689293	GS1
Unit of Use	40884521689290	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			No;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;AVOID DIRECT SUNLIGHT