MFT 25 _ AIR DS _ 9/16 G - Mediflow devices are intended for the - GCE, s.r.o.

Duns Number:819753190

Device Description: Mediflow devices are intended for the administration of the following medical gases in the Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.

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More Product Details

Catalog Number

-

Brand Name

MFT 25 _ AIR DS _ 9/16 G

Version/Model Number

0726502US

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

CAX

Product Code Name

Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Device Record Status

Public Device Record Key

d18c3dd5-0a9a-4dee-a1c3-dd0f2b6a771f

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