ADVOCATE ORAL & RECTAL THERMOMETER

Basic Information

• Brand Name: ADVOCATE ORAL & RECTAL THERMOMETER
• Primary DI: 00852982006354
• Version / Model: 145
• Catalog Number: 145
• Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.
• Labeler DUNS: 043081723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-06
• Public Version: 8
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 4520a555-241f-426c-8cbc-eddd6d9a7569

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20852982006358	GS1	145-C	96	In Commercial Distribution
Package	10852982006351	GS1	145-INNER	16	In Commercial Distribution
Primary	00852982006354	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101387	000