Disposable Thermometer Cover and Sheaths

Basic Information

• Brand Name: Disposable Thermometer Cover and Sheaths
• Primary DI: 06972543480110
• Version / Model: 9028
• Company Name: KANG ZE INDUSTRIAL CO., LTD
• Labeler DUNS: 542345014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 21600
• Record Status: Published
• Publish Date: 2019-08-23
• Public Version: 1
• Public Version Date: 2019-09-02
• Public Version Status: New
• Public Device Record Key: 85bdd233-d4fe-49c3-9336-da887b05c8a2

Device Description

The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

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: Yes
• 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
FLK	Thermometer, Clinical Mercury	General Hospital	880.2920	2
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	06972543480110	GS1
Unit of Use	06972543480080	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112289	000