Catalog Number

-

Brand Name

Bionso

Version/Model Number

PC828

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

-

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

K172889,K172889

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9d35a074-4017-43b8-8389-d521fb9767f8

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Package DI Number

10840061482837

Quantity per Package

50

Contains DI Package

00840061482830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package box