Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11003

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

e3794204-fd6f-4323-9f53-77b56de3db3b

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 31, 2018

Package DI Number

60368001110039

Quantity per Package

4

Contains DI Package

20368001110031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case