Catalog Number

900909

Brand Name

Flexi Air Tip XL

Version/Model Number

900909

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"

-

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

0804578e-e3b3-487f-9733-14d90a9415ec

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020898

Quantity per Package

480

Contains DI Package

10815112020894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box