Catalog Number

-

Brand Name

bioland

Version/Model Number

E127

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

K201161,K201161,K201161

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

5f0fde93-76b7-418c-86b7-af1e1c59b11a

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

October 21, 2020

Package DI Number

16939184620005

Quantity per Package

20

Contains DI Package

06939184620008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-