Catalog Number

-

Brand Name

Tesio® Extension Set

Version/Model Number

AAC11004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 05, 2020

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

3270dd25-64ce-454d-a7a3-0bc96fe50fc1

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 22, 2015

Package DI Number

50884908000523

Quantity per Package

10

Contains DI Package

00884908000528

Package Discontinue Date

August 05, 2020

Package Status

Not in Commercial Distribution

Package Type

box