Catalog Number

-

Brand Name

GBUK GROUP LIMITED

Version/Model Number

CDT-001

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

756e6603-bf1c-411b-9431-f4e7bfa6a473

Public Version Date

April 22, 2022

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

24719873438307

Quantity per Package

10

Contains DI Package

04719873438303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-