Catalog Number

DDFXL149IJC

Brand Name

400XL IJ400XL IJ

Version/Model Number

DDFXL149IJC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2021

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

34c45cbc-8712-4fee-827c-16b29562b1c6

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

July 31, 2019

Package DI Number

50884908145316

Quantity per Package

5

Contains DI Package

00884908145311

Package Discontinue Date

July 12, 2021

Package Status

Not in Commercial Distribution

Package Type

box