Catalog Number

QC-99220

Brand Name

QUALITY CHOICE

Version/Model Number

89-355

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K041516,K041516,K041516

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a3707cf0-c38e-42a3-814f-672d23b639fb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 15, 2017

Package DI Number

30635515992208

Quantity per Package

6

Contains DI Package

00635515992207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INTERMEDIATE