Catalog Number

QC-98679

Brand Name

QUALITY CHOICE

Version/Model Number

89-50K

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

6d688442-97c6-4daa-b5a7-b81db0c4fbcb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 15, 2017

Package DI Number

30635515986795

Quantity per Package

4

Contains DI Package

00635515986794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INTERMEDIATE