AccessGUDID - DEVICE: Kwik-Skan® (B23951301)

GUDID

Device Identifier (DI) Information

Brand Name: Kwik-Skan®
Version or Model: 5130
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5130
Company Name: TRADEMARK MEDICAL, L.L.C.

Primary DI Number: B23951301
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2018
Device Count: 100
Labeler D-U-N-S® Number*: 024113805 *Terms of Use

Device Description: Liquid crystal temperature monitor strip (oval), dispenser box

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:	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e113dc7-6067-4031-ab26-722631a8476d
Public Version Date: September 22, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016