MFU25 _ O2 DN _ 9/16 S - 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.

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More Product Details

Catalog Number

-

Brand Name

MFU25 _ O2 DN _ 9/16 S

Version/Model Number

0728106US

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

ff868760-c371-44df-8e10-23fd86a43e3d

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

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