Podimetrics Remanufactured SmartMat PMHS201U-R

GUDID 00866538000314

Foot examination tool for inflammatory changes.

Podimetrics, Inc.

Temperature telemetric monitoring system

• Primary Device ID: 00866538000314
• NIH Device Record Key: 6a2f1d3c-0af3-4ce7-a26c-d8ca60ba4d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Podimetrics Remanufactured SmartMat
• Version Model Number: PMHS201U-R
• Catalog Number: PMHS201U-R
• Company DUNS: 078861191
• Company Name: Podimetrics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com
• Phone: 617-616-5269
• Email: regulatory@podimetrics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866538000314 [Primary]

FDA Product Code

• OIZ: Foot Examination Tool For Inflammatory Changes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-15
• Device Publish Date: 2021-09-07

Devices Manufactured by Podimetrics, Inc.

• 00866538000321 - Podimetrics Wi-Fi SmartMat: 2024-04-15 Foot examination tool for inflammatory changes.
• 00866538000307 - Podimetrics SmartMat: 2021-09-15 Foot examination tool for inflammatory changes.
• 00866538000314 - Podimetrics Remanufactured SmartMat: 2021-09-15Foot examination tool for inflammatory changes.
• 00866538000314 - Podimetrics Remanufactured SmartMat: 2021-09-15 Foot examination tool for inflammatory changes.