Catalog Number

-

Brand Name

SafeFit

Version/Model Number

EF 120

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)

-

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

d2ae866d-e8a6-4185-aa61-0e023dfc019f

Public Version Date

January 30, 2020

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

813153024461

Quantity per Package

1

Contains DI Package

10813153024468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-