Vyaire - EXPIRATORY PRESSURE VALVE - Vyaire Medical GmbH

Duns Number:329769991

Device Description: EXPIRATORY PRESSURE VALVE

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More Product Details

Catalog Number

36-ASS1221

Brand Name

Vyaire

Version/Model Number

36-ASS1221

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

K940375

Product Code Details

Product Code

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Device Record Status

Public Device Record Key

d3ed4fa9-b81f-4833-b66c-6ab47e9982e9

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

May 28, 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