Catalog Number

20-1362

Brand Name

CORFLO ULTRA Lite NG

Version/Model Number

20-1362

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

c3ddbc1a-2e62-4915-8cdb-9e801bb9e46f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2016

Package DI Number

20815149023070

Quantity per Package

10

Contains DI Package

10815149023073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-