Catalog Number

30634045

Brand Name

Kendall

Version/Model Number

30634045

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DSF

Product Code Name

RECORDER, PAPER CHART

Public Device Record Key

917340a5-dcd7-423c-83dd-bc13044bf28d

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 23, 2018

Package DI Number

20884527009722

Quantity per Package

20

Contains DI Package

10884527009725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE