AccessGUDID - DEVICE: Podimetrics Remanufactured SmartMat (00866538000314)

GUDID

Device Identifier (DI) Information

Brand Name: Podimetrics Remanufactured SmartMat
Version or Model: PMHS201U-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMHS201U-R
Company Name: Podimetrics, Inc.

Primary DI Number: 00866538000314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078861191 *Terms of Use

Device Description: Foot examination tool for inflammatory changes.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OIZ	Foot Examination Tool For Inflammatory Changes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a2f1d3c-0af3-4ce7-a26c-d8ca60ba4d0c
Public Version Date: September 15, 2021
Public Version Number: 1
DI Record Publish Date: September 07, 2021