Catalog Number

390309

Brand Name

Protocol Touch Administration Set with Small Catheter and Retention Cuff

Version/Model Number

390309

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

-

Product Code

FCX

Product Code Name

Insufflator, Automatic Carbon-Dioxide For Endoscope

Public Device Record Key

52bc450b-b3c7-43ac-8176-1ab8fecc1110

Public Version Date

June 30, 2020

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020157

Quantity per Package

24

Contains DI Package

10815112020153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box