Catalog Number

ADY10

Brand Name

ADI Medical

Version/Model Number

ADY10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2018

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)

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

c0c188e9-3c7e-4157-8be1-4a10b583b6b4

Public Version Date

August 13, 2019

Public Version Number

4

DI Record Publish Date

January 04, 2017

Package DI Number

10755676000003

Quantity per Package

20

Contains DI Package

00755676000006

Package Discontinue Date

January 04, 2018

Package Status

Not in Commercial Distribution

Package Type

Case