Jaeger - MicroGard II, bacterial/viral filter - Vyaire Medical GmbH

Duns Number:329769991

Device Description: MicroGard II, bacterial/viral filter

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More Product Details

Catalog Number

V-892384

Brand Name

Jaeger

Version/Model Number

V-892384

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2020

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)

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

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

0cec6653-eeb6-4b9d-8709-09a2f726f2dd

Public Version Date

March 16, 2021

Public Version Number

6

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 76
2 A medical device with a moderate to high risk that requires special controls. 416