Vyaire - USS Module - Vyaire Medical GmbH

Duns Number:329769991

Device Description: USS Module

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More Product Details

Catalog Number

V-707377

Brand Name

Vyaire

Version/Model Number

V-707377

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181524

Product Code Details

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Device Record Status

Public Device Record Key

2ddc6d10-360e-47c1-9899-a757f59577ed

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

July 03, 2019

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