Catalog Number

Not Applicable

Brand Name

MedSource Manual Suction Pump

Version/Model Number

STORM-001PMP

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

-

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

7449f895-c494-4f9c-8155-db4fec90ec64

Public Version Date

September 02, 2021

Public Version Number

1

DI Record Publish Date

August 25, 2021

Package DI Number

00840155408098

Quantity per Package

10

Contains DI Package

00840155408081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case