Catalog Number

M8125-P

Brand Name

DeRoyal

Version/Model Number

M8125-P

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

-

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

9e395d3d-125a-4ea1-a3b2-9236048ae91b

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

50749756112500

Quantity per Package

30

Contains DI Package

00749756112505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case