Catalog Number

-

Brand Name

G.E.B. tubing

Version/Model Number

1

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)

-

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

7dad742f-113b-4489-994b-294edecd9130

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2019

Package DI Number

50860000082810

Quantity per Package

50

Contains DI Package

10860000082812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-