Catalog Number

54-1204

Brand Name

MED-RX

Version/Model Number

54-1204

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

K100700,K100700

Product Code

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

c7ca0591-919c-47da-84a3-23ca48c4a3c2

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

50628725003677

Quantity per Package

100

Contains DI Package

00628725003672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CORRUGATE CASE