Catalog Number

-

Brand Name

HxhyTope

Version/Model Number

AOJ-20E

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

K182133

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

b2470b1b-4ad4-4657-bd04-6c3abf6334b7

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

October 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-