Catalog Number

-

Brand Name

HYLOGY

Version/Model Number

BY-01

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)

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

5918d4be-df23-45ad-ac90-4ef5c2952547

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

February 19, 2019

Package DI Number

36947656112464

Quantity per Package

80

Contains DI Package

06947656112463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cartoon