AirLife™ - AirLife™ flow-inflating tail-end valve transport - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: AirLife™ flow-inflating tail-end valve transport circuit

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More Product Details

Catalog Number

5104RVX1

Brand Name

AirLife™

Version/Model Number

5104RVX1

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

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Device Record Status

Public Device Record Key

20a4fc91-c15f-41c6-8fad-2848c9ae8be1

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

50190752146158

Quantity per Package

20

Contains DI Package

10190752146150

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