iLifeplus

GUDID B459SY18210

PURE LIFE SOLUTIONS INC.

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