Catalog Number

-

Brand Name

GaleMed

Version/Model Number

73038

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

-

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

c01310b5-5570-4393-827e-2cfa0d025c24

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2015

Package DI Number

44710810085206

Quantity per Package

500

Contains DI Package

04710810085208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton