Isansys

Basic Information

• Brand Name: Isansys
• Primary DI: 05060488680038
• Version / Model: Lifetemp Sensor - Large
• Catalog Number: Lifetemp Sensor - Large
• Company Name: ISANSYS LIFECARE LIMITED
• Labeler DUNS: 216707432
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-26
• Public Version: 1
• Public Version Date: 2024-05-06
• Public Version Status: New
• Public Device Record Key: 2b9e74cc-6eaf-44d9-a55c-d3fe2ed12c7f

Device Description

Continuous Clinical Thermometer

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64902	Physiological measuring device wireless data capture/transfer unit	A mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488680038	GS1

Premarket Submissions

Submission Number	Supplement Number
K172329	000