Catalog Number

-

Brand Name

PNEUMOCLEAR

Version/Model Number

FM300

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

K170784

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

1d9d460d-7002-4a12-aab4-8ad5f198214e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-