Catalog Number

ST-100

Brand Name

Tablo Straws

Version/Model Number

PN-0000503

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 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"

-

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

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

42ff25f5-97ac-40b5-855a-17609bd201ba

Public Version Date

August 04, 2020

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

30850001011021

Quantity per Package

50

Contains DI Package

20850001011024

Package Discontinue Date

August 03, 2020

Package Status

Not in Commercial Distribution

Package Type

Pouch