Catalog Number

-

Brand Name

N/A

Version/Model Number

RM21341

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

3f840599-87ed-4c16-88a8-a59b25532584

Public Version Date

February 07, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

05030267118991

Quantity per Package

50

Contains DI Package

00619498213412

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-