Catalog Number

-

Brand Name

Wellue

Version/Model Number

G-427B

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

K191657,K191657

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

cb428e9a-15c8-452d-8c9b-084883c8040b

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Package DI Number

16934440100000

Quantity per Package

10

Contains DI Package

06934440101093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-