AccessGUDID - DEVICE: DermaTherm (10815236020008)

GUDID

Device Identifier (DI) Information

Brand Name: DermaTherm
Version or Model: 2100PB-SB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SSH2100PB-SB
Company Name: LCR HALLCREST, LLC.

Primary DI Number: 10815236020008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 059247507 *Terms of Use

Device Description: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pain Management Department to diagnose RSD, as well as to assess the effectiveness of nerve blocks within minutes by watching for a sympathetic rise in temperature. They are also useful when doing EMGs.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPD	Strip, Temperature, Forehead, Liquid Crystal

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Optimal Storage and Handling Conditions are 16 to 27°C (60-80°F) and 40-60% Relative Humidity
Storage Environment Temperature: between 16 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b9324ff-bd87-4bea-b29a-6569d1d154cb
Public Version Date: February 24, 2020
Public Version Number: 3
DI Record Publish Date: September 23, 2016