Catalog Number

1504RBM N

Brand Name

Bemis

Version/Model Number

1504RBM N

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K771737,K771737

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

dc921075-36dc-4ae2-b1f6-a1bbbfafd2e9

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-