AccessGUDID - DEVICE: MABIS (00767056157491)

GUDID

Device Identifier (DI) Information

Brand Name: MABIS
Version or Model: 15-749-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 15-749-000
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00767056157491
Issuing Agency: GS1
Commercial Distribution End Date: May 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: HOSPITAL PACK DUAL SCALE DIGITAL THERMOMETER W/20 PROBE COVERS/RECTAL

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):	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?
14034	Continuous electronic patient thermometer, battery-powered	A battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.	Active	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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 861f09b6-8dd9-49f6-8116-6aaea47ba3e4
Public Version Date: May 17, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10767056157498	6	30767056157492	2023-05-16	Not in Commercial Distribution	Master Carton
30767056157492	12	00767056157491	2023-05-16	Not in Commercial Distribution	Inner Carton