Catalog Number

-

Brand Name

Tesio® Extension Set

Version/Model Number

AAC11003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

1ad96e47-1601-49ee-aef9-749b2876adf7

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 22, 2015

Package DI Number

50884908000516

Quantity per Package

10

Contains DI Package

00884908000511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box