SteadyTemp

Basic Information

• Brand Name: SteadyTemp
• Primary DI: 09120095900281
• Version / Model: 1
• Company Name: SteadySense GmbH
• Labeler DUNS: 300492871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-15
• Public Version: 1
• Public Version Date: 2024-07-23
• Public Version Status: New
• Public Device Record Key: 820f6460-50a0-409c-ad67-767b3ec60c20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
62170	Wireless patient thermometer, single-use	A battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit), and is typically used to monitor a fever during daily activities and sleep. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09120095900281	GS1

Premarket Submissions

Submission Number	Supplement Number
K233280	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius