MedSource Tank Regulator - AMVEX M-TANK REGULATOR - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: AMVEX M-TANK REGULATOR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MedSource Tank Regulator

Version/Model Number

MS-CGA540-RCS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

c117aa0c-2d87-4b5e-9cd5-908097ffbfee

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90