Catalog Number

4524-HD

Brand Name

GaleMed

Version/Model Number

5409

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

K102377,K102377,K102377

Product Code

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Public Device Record Key

c61442ed-b47b-446d-a180-afbffd5bd7c4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2015

Package DI Number

44710810100305

Quantity per Package

12

Contains DI Package

24710810100301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton