Catalog Number

-

Brand Name

Pulsair Intellipuff

Version/Model Number

2414-P-2001

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093298

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Public Device Record Key

a4893682-fde3-4cd9-b5ad-5dcc9c88718a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-