Catalog Number

QC-95697

Brand Name

QUALITY CHOICE

Version/Model Number

89-331

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

K032362,K032362,K032362

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

637228a0-f7ba-43d3-92f1-24bf961f6aeb

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

February 15, 2017

Package DI Number

10635515956978

Quantity per Package

36

Contains DI Package

30635515956972

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton