AccessGUDID - DEVICE: The Fitness Family (00866066000305)

GUDID

Device Identifier (DI) Information

Brand Name: The Fitness Family
Version or Model: 001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GMB INTERNATIONAL LIMITED

Primary DI Number: 00866066000305
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 221516566 *Terms of Use

Device Description: A digital thermometer designed to measure body temperature orally, rectally or under the arm. It has a silicon & plastic structure, a metal sensing tip and a battery-powered chip and LCD screen. It is for multiple uses.

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
14025	Thermometer kit	A collection of devices intended to be used to eliminate the reprocessing, reduce the risk of breakage and cross-contamination, and reduce the variance caused by the use of more than one thermometer per patient. It typically includes a thermometer [e.g., a mercury (Hg) or alcohol thermometer] for measuring human body temperature; and other components such as holders, cases, vials, or sheaths. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

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: e06d139f-65b0-4598-8aaf-d419fdb56bac
Public Version Date: December 31, 2018
Public Version Number: 3
DI Record Publish Date: May 13, 2017