Catalog Number

-

Brand Name

Critikon

Version/Model Number

2405

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2019

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032821,K032821

Product Code

NPP

Product Code Name

Reprocessed Blood Pressure Cuff

Public Device Record Key

70015f26-3a53-46c9-a691-da1f670017db

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

30817357021968

Quantity per Package

20

Contains DI Package

10817357021964

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box