Catalog Number

-

Brand Name

Adaptors/Connectors

Version/Model Number

S6411P

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"

Yes

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

12026398-2d67-4121-a256-16a174208fcd

Public Version Date

June 08, 2021

Public Version Number

1

DI Record Publish Date

May 31, 2021

Package DI Number

10709078012485

Quantity per Package

50

Contains DI Package

00709078012488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-