AirLife™ - AirLife™ Meconium Suction Device (Kurtis MSD) - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: AirLife™ Meconium Suction Device (Kurtis MSD)

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More Product Details

Catalog Number

4535EU

Brand Name

AirLife™

Version/Model Number

4535EU

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"

Yes

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

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

fdf59187-c9e0-43e3-84b3-ab8ce777434a

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

50190752144529

Quantity per Package

10

Contains DI Package

10190752144521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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