Catalog Number

1809

Brand Name

Motion Medical Distributing

Version/Model Number

1809

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OKH

Product Code Name

Body Fluids Barrier Kit

Public Device Record Key

6f6452d5-e610-41a0-a984-edd97784cfc4

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

25060498452117

Quantity per Package

10

Contains DI Package

15060498452110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case