AVEA™ - Ventilator Esophageal Pressure Monitoring Tube Set - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: Ventilator Esophageal Pressure Monitoring Tube Set

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More Product Details

Catalog Number

3001083

Brand Name

AVEA™

Version/Model Number

3001083

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

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

K103211

Product Code Details

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Device Record Status

Public Device Record Key

47d2bcfa-e646-4ec7-a8f0-699e776a751e

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 780
3 A medical device with high risk that requires premarket approval 65
U Unclassified 1