Catalog Number

56472

Brand Name

Devon

Version/Model Number

56472

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

b463f700-fcf1-4915-8e58-6d80f2375c1f

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

May 03, 2017

Package DI Number

10884527007707

Quantity per Package

8

Contains DI Package

20884527007704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE