Catalog Number

989803182521

Brand Name

MR Patient Care Pediatric NBP Cuffs (10)

Version/Model Number

Pediatric NBP Cuffs (10)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Public Device Record Key

f8cfd32e-fcf5-4a58-b338-32195243e651

Public Version Date

August 22, 2022

Public Version Number

3

DI Record Publish Date

May 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-