FeetMe Monitor Charging Case FTM-DK-CC

Basic Information

• Brand Name: FeetMe Monitor Charging Case FTM-DK-CC
• Primary DI: 03760349820116
• Version / Model: V2
• Company Name: FEETME
• Labeler DUNS: 265478109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: aaab1189-c5dd-4b3e-a0a6-fd4181559714

Device Description

Device is a charging and transportation case for up to 12 pair of FTM-DK insoles

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760349820116	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius