Catalog Number

16811-PRBO

Brand Name

CARDINAL HEALTH

Version/Model Number

16811-PRBO

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)

Yes

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

68055b3f-b25e-4606-9965-d1e9a237cd04

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50885380023857

Quantity per Package

20

Contains DI Package

20885380023856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE