iLifeplus - PURE LIFE SOLUTIONS INC.

Duns Number:080406332

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More Product Details

Catalog Number

-

Brand Name

iLifeplus

Version/Model Number

JPD-FR401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131243

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

4d91358e-033d-40f0-ab57-47e86019af28

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

March 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PURE LIFE SOLUTIONS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4