Catalog Number

-

Brand Name

BIOS

Version/Model Number

227DI

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

5e589236-d9fe-4387-b3b2-c903647f98a3

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 04, 2022

Package DI Number

10057475227491

Quantity per Package

6

Contains DI Package

00057475227494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case