FlowArt® - Six Port Flexible Manifold w/Split Septum - ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI

Duns Number:365581688

Device Description: Six Port Flexible Manifold w/Split Septum Needle-Free Valves and Integrated Back Check Val

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More Product Details

Catalog Number

-

Brand Name

FlowArt®

Version/Model Number

AYWB7010CV

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190806,K190806

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

6c4a7b44-8c66-4587-8dc3-cb7b53ac32fd

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Additional Identifiers

Package DI Number

28699443585074

Quantity per Package

50

Contains DI Package

08699443585070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18