Catalog Number

989803169431

Brand Name

Cuff, Infant, MRI, Colder Conn

Version/Model Number

Cuff, Infant, MRI, Colder Conn

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2022

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

-

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

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Public Device Record Key

0c729b85-a4f0-4423-a76a-53f8e89a94de

Public Version Date

March 16, 2022

Public Version Number

7

DI Record Publish Date

March 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-