VYGON - 0.2 MICRON SUPOR GARDIAN FILTER 25mm FLL/MLL - Vygon Corporation

Duns Number:120818216

Device Description: 0.2 MICRON SUPOR GARDIAN FILTER 25mm FLL/MLL

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More Product Details

Catalog Number

AMS-949

Brand Name

VYGON

Version/Model Number

AMS-949

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"

-

For Single-Use

Yes

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

FPB

Product Code Name

Filter, infusion line

Device Record Status

Public Device Record Key

e5fe0f26-a1e3-467a-967c-10e3d8beda70

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

38498840005263

Quantity per Package

50

Contains DI Package

08498840005262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 833