LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295130065
• Version / Model: 5295142
• Catalog Number: 5295142
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 5
• Public Version Date: 2023-03-08
• Public Version Status: Update
• Public Device Record Key: 8b4bff83-5907-4908-b581-3e348ba48266
• Distribution End Date: 2020-03-17

Device Description

LDR Digital Thermometer Probe covers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
Package	30096295130066	GS1	PACK	24	Not in Commercial Distribution	2020-03-17
Primary	00096295130065	GS1
Package	50096295130060	GS1	CASE	3	Not in Commercial Distribution	2020-03-17
Unit of Use	10096295130062	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102508	000