Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS9000

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"

Yes

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

6de3d913-999f-4f06-9137-ed9c0f385724

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

10849027002522

Quantity per Package

72

Contains DI Package

00849027002525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case