Catalog Number

M2200-BP

Brand Name

N/A

Version/Model Number

M2200-BP

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

f17a773e-f011-4aa8-859a-4421bebaca64

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Package DI Number

57613327512637

Quantity per Package

15

Contains DI Package

07613327512632

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case