iLifeplus

GUDID B459SY18210

PURE LIFE SOLUTIONS INC.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

Primary Device ID	B459SY18210
NIH Device Record Key	4d91358e-033d-40f0-ab57-47e86019af28
Commercial Distribution Discontinuation	2018-12-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	iLifeplus
Version Model Number	JPD-FR401
Company DUNS	080406332
Company Name	PURE LIFE SOLUTIONS INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B459SY18210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131243

FDA Product Code

FLL	Thermometer, Electronic, Clinical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-12-31
Device Publish Date	2017-03-24

On-Brand Devices [iLifeplus]

B459SY18210	JPD-FR401
B459SY18200	ABP-U80R
B459SY18190	JPD-FR200
B459SY18220	JPD-FR200