Catalog Number

390402

Brand Name

Protocol Administration Set with Small Catheter and Retention Cuff

Version/Model Number

390402

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

K030854,K030854

Product Code

FCX

Product Code Name

Insufflator, Automatic Carbon-Dioxide For Endoscope

Public Device Record Key

2845c31d-8169-4381-9d47-5d333c578153

Public Version Date

June 30, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020171

Quantity per Package

24

Contains DI Package

10815112020177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box