Podimetrics Remanufactured SmartMat

Basic Information

• Brand Name: Podimetrics Remanufactured SmartMat
• Primary DI: 00866538000314
• Version / Model: PMHS201U-R
• Catalog Number: PMHS201U-R
• Company Name: Podimetrics, Inc.
• Labeler DUNS: 078861191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-07
• Public Version: 1
• Public Version Date: 2021-09-15
• Public Version Status: New
• Public Device Record Key: 6a2f1d3c-0af3-4ce7-a26c-d8ca60ba4d0c

Device Description

Foot examination tool for inflammatory changes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13990	Temperature telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit a patient's core and/or skin temperature to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable radio transmitter and skin, tympanic, rectal, oesophageal, and/or ingestible temperature sensors that are attached to the patient; and a bedside or central station receiver which detects the radio waves and displays and/or processes the temperature values using computing capabilities. The device is used mainly to evaluate the physiologic status of persons under or after severe physical stress and/or effort.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866538000314	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 45 Degrees Celsius