Catalog Number

-

Brand Name

AMPMED

Version/Model Number

AMPAE3W

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

K171578

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

22cbac4a-a0e8-47c1-af6e-467e1e46a938

Public Version Date

May 14, 2021

Public Version Number

1

DI Record Publish Date

May 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-