Catalog Number

390308

Brand Name

Protocol Touch Colon Insufflator

Version/Model Number

390308

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

-

Product Code

FCX

Product Code Name

Insufflator, Automatic Carbon-Dioxide For Endoscope

Public Device Record Key

3c79edfd-6c16-496b-925e-f675699862d2

Public Version Date

September 21, 2021

Public Version Number

1

DI Record Publish Date

September 13, 2021

Package DI Number

30815112020676

Quantity per Package

1

Contains DI Package

10815112020672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box