Catalog Number

00088111

Brand Name

VYGON

Version/Model Number

881.11

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

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Public Device Record Key

7b4d0541-b36f-4755-970e-e535c3915f89

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

33660812130333

Quantity per Package

30

Contains DI Package

03660812130332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box