Catalog Number

P541222

Brand Name

Pro Advantage

Version/Model Number

P541222

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K940686,K940686,K940686

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2ebb4a9d-a2b0-4731-9d74-70a6b7b88dd5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

M220P5412225

Quantity per Package

12

Contains DI Package

M220P5412223

Package Discontinue Date

-

Package Status

-

Package Type

Case