Bestmed

Basic Information

• Brand Name: Bestmed
• Primary DI: 00809148009537
• Version / Model: K-953.BM
• Company Name: 180 INNOVATIONS LLC
• Labeler DUNS: 126646582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 77f4f61f-a9ad-44fe-ae43-81bc0a54aa7f

Device Description

30 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.

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	20809148009531	GS1	inner carton	6	In Commercial Distribution
Primary	00809148009537	GS1
Package	40809148009535	GS1	case	24	In Commercial Distribution

Customer Contacts

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