Catalog Number

900404

Brand Name

Blue Air Bulb Insufflator

Version/Model Number

900404

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

FGD

Product Code Name

Catheter, Retention, Barium Enema With Bag

Public Device Record Key

0e8071fd-14e7-48e4-a2bf-ffc4e16f899d

Public Version Date

June 30, 2020

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020874

Quantity per Package

12

Contains DI Package

10815112020870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box