Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

63-515

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

K091272,K091272

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

0ec2063e-37a4-42d1-81e5-02ac577206f4

Public Version Date

August 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

40872237005091

Quantity per Package

50

Contains DI Package

00872237005093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE