Catalog Number

QC-95147

Brand Name

QUALITY CHOICE

Version/Model Number

89-328

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

Yes

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

c19fed1f-781c-4269-935c-70b0a2735eb7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 15, 2017

Package DI Number

10635515951478

Quantity per Package

24

Contains DI Package

30635515951472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton