Jaeger - MasterScreen Body/Diff - Vyaire Medical GmbH

Duns Number:329769991

Device Description: MasterScreen Body/Diff

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More Product Details

Catalog Number

V-175420

Brand Name

Jaeger

Version/Model Number

V-175420

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2019

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

-

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

BZC

Product Code Name

Calculator, Pulmonary Function Data

Device Record Status

Public Device Record Key

dc7b5ac4-d0bc-41e5-8271-e57d9824f4d4

Public Version Date

March 16, 2021

Public Version Number

5

DI Record Publish Date

August 02, 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