Catalog Number

AFTD

Brand Name

MD Resource

Version/Model Number

AFTD

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

809f9e90-812f-4aa0-84b5-bbac6a2a5d98

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 30, 2016

Package DI Number

00859898006041

Quantity per Package

6

Contains DI Package

00859898006034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-