Catalog Number

-

Brand Name

GaleMed

Version/Model Number

2429-01

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

K133957,K133957,K133957

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

bdd57339-409b-4d60-b6b6-5702e556d9e1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2015

Package DI Number

44710810082915

Quantity per Package

5

Contains DI Package

24710810082911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton