Truer Medical, Inc.

Basic Information

• Brand Name: Truer Medical, Inc.
• Primary DI: 00859290006113
• Version / Model: GP 9400
• Catalog Number: GP 9400
• Company Name: TRUER MEDICAL, INC.
• Labeler DUNS: 003530786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b9e99d6b-309e-42c4-82a7-d7cc4a553fa1

Device Description

Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Primary	00859290006113	GS1
Package	40859290006111	GS1	Carton	6	In Commercial Distribution
Package	30859290006114	GS1	Carton	5	In Commercial Distribution
Package	20859290006117	GS1	Carton	2	In Commercial Distribution
Package	10859290006110	GS1	Carton	50	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101244	000