GENTEC® - FMD197A Series, Dual Flowmeter, Oxygen, Aluminum, - GENTEC(SHANGHAI)CORPORATION

Duns Number:545287658

Device Description: FMD197A Series, Dual Flowmeter, Oxygen, Aluminum, 1L,3L,6L,15L,50L,70L.

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More Product Details

Catalog Number

-

Brand Name

GENTEC®

Version/Model Number

FMD197A Series

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 21, 2032

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

f2cf8f64-bf39-49b6-b707-45f47f4209ef

Public Version Date

April 29, 2022

Public Version Number

1

DI Record Publish Date

April 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENTEC(SHANGHAI)CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 258