MOBI

Basic Information

• Brand Name: MOBI
• Primary DI: 00891040000262
• Version / Model: 700026
• Company Name: MOBI TECHNOLOGIES, INC.
• Labeler DUNS: 137468570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-31
• Public Version: 1
• Public Version Date: 2022-08-08
• Public Version Status: New
• Public Device Record Key: fa624a42-2151-434f-9ae6-97963c300d47

Device Description

Smart DualScan Ear + Forehead Bluetooth Thermometer

Device Characteristics

• Single Use: No
• 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
63711	Infrared patient thermometer, ear/skin	A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10891040000269	GS1	Cardboard	3	In Commercial Distribution
Primary	00891040000262	GS1
Package	20891040000266	GS1	Cardboard	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K172795	000