Catalog Number

Not Applicable

Brand Name

MedSource Suction Catheter

Version/Model Number

MS-SC08

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

f28b8320-3136-4177-b35a-d9f29c8747dd

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Package DI Number

00816703027547

Quantity per Package

50

Contains DI Package

00816703027530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case