Catalog Number

8283

Brand Name

N/A

Version/Model Number

8283

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KMI

Product Code Name

MONITOR, BED PATIENT

Public Device Record Key

1acc7d5b-5c40-44cc-b845-672e6e9807fb

Public Version Date

April 28, 2022

Public Version Number

3

DI Record Publish Date

July 18, 2019

Package DI Number

57613327500238

Quantity per Package

6

Contains DI Package

07613327500233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case