PaediGAV® - PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24 - Christoph Miethke GmbH & Co. KG

Duns Number:343189676

Device Description: PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24

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More Product Details

Catalog Number

FV306T

Brand Name

PaediGAV®

Version/Model Number

FV306T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

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

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

cbf8db2d-fada-4faa-95a4-d66fbbecb03c

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHRISTOPH MIETHKE GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 630