Catalog Number

Not Applicable

Brand Name

MedSource I.V. Guard

Version/Model Number

MS-11108

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

4798ab8b-3362-4ba6-8851-b6ac7d82d55e

Public Version Date

May 06, 2021

Public Version Number

1

DI Record Publish Date

April 28, 2021

Package DI Number

00840155407855

Quantity per Package

1

Contains DI Package

00816703024553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case