Catalog Number

-

Brand Name

AMPMED

Version/Model Number

AMP2001W2

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

K210565

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

6038e37e-5edd-4471-a9f6-b338bcc97cec

Public Version Date

September 28, 2022

Public Version Number

4

DI Record Publish Date

March 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-