Catalog Number

MNS2925B

Brand Name

Centurion

Version/Model Number

MNS2925B

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"

Yes

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

MLS

Product Code Name

Labor and Delivery Kit

Public Device Record Key

955eaeb9-c56d-4b6f-a154-7295bf05232c

Public Version Date

February 11, 2020

Public Version Number

1

DI Record Publish Date

February 03, 2020

Package DI Number

00653160341232

Quantity per Package

10

Contains DI Package

10653160341239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE