Catalog Number

M1045564

Brand Name

N/A

Version/Model Number

M1045564

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

BXO

Product Code Name

Transducer, Gas Pressure

Public Device Record Key

68bc68cb-46ed-4068-bb2e-a8bf4c8956bf

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Package DI Number

20190752143835

Quantity per Package

10

Contains DI Package

10190752143838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-