Catalog Number

390302

Brand Name

Protocol Colon Insufflator Demo Unit

Version/Model Number

390302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030854,K030854

Product Code

FCX

Product Code Name

Insufflator, Automatic Carbon-Dioxide For Endoscope

Public Device Record Key

756e3d7b-e2a9-4f37-9ee3-634b3aafeb80

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

30815112021130

Quantity per Package

1

Contains DI Package

10815112021136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box