Isansys Lifetemp Sensor - V2 - Medium

GUDID 05060488680052

Continuous Clinical Thermometer

ISANSYS LIFECARE LIMITED

Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit Physiological measuring device wireless data capture/transfer unit

Primary Device ID	05060488680052
NIH Device Record Key	9cdb2fef-fe7d-42ae-b8e5-72dd366017df
Commercial Distribution Status	In Commercial Distribution
Brand Name	Isansys
Version Model Number	Lifetemp Sensor - V2 - Medium
Catalog Number	Lifetemp Sensor - V2 - Medium
Company DUNS	216707432
Company Name	ISANSYS LIFECARE LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060488680052 [Package] Contains: 05060488680281 Package: Carton box [10 Units] In Commercial Distribution
GS1	05060488680281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172329

FDA Product Code

DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

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