MR AIR CGA346 DS _ _ G - The regulator acts as a pressure-reducer, gas - GCE, s.r.o.

Duns Number:819753190

Device Description: The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the p The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.

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


More Product Details

Catalog Number

-

Brand Name

MR AIR CGA346 DS _ _ G

Version/Model Number

0724103US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

cf573c74-5250-42bc-8991-ee2966415d1d

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GCE, S.R.O." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 6