AccessGUDID - DEVICE: ADVOCATE ORAL & RECTAL THERMOMETER (00852982006354)

GUDID

Device Identifier (DI) Information

Brand Name: ADVOCATE ORAL & RECTAL THERMOMETER
Version or Model: 145
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 145
Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.

Primary DI Number: 00852982006354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043081723 *Terms of Use

Device Description: Advocate Thermometer, Oral/Rectal, flexible tip probe, beep alert with 8 second results, large digital display, "F"arenheit & "C"elsius, last memory recall, water resistant,

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
35254	General-purpose patient temperature probe, single-use	A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101387	000

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: 4520a555-241f-426c-8cbc-eddd6d9a7569
Public Version Date: November 06, 2023
Public Version Number: 8
DI Record Publish Date: February 06, 2017