Catalog Number

54-5003

Brand Name

MED-RX

Version/Model Number

54-5003

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

3a604da9-37d2-4222-837f-d0c3c09e0855

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Package DI Number

50628725003042

Quantity per Package

150

Contains DI Package

00628725003047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugate Case