Catalog Number

-

Brand Name

400XL

Version/Model Number

AAC26414

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2020

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

MPB

Product Code Name

CATHETER, HEMODIALYSIS, NON-IMPLANTED

Public Device Record Key

f176832d-3787-450d-9241-3176c478a93c

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

April 29, 2016

Package DI Number

50884908001469

Quantity per Package

5

Contains DI Package

00884908001464

Package Discontinue Date

June 23, 2020

Package Status

Not in Commercial Distribution

Package Type

box