AirLife™ - Corrugated Flexible Polyethylene and EVA Tubing - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: Corrugated Flexible Polyethylene and EVA Tubing

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More Product Details

Catalog Number

001427

Brand Name

AirLife™

Version/Model Number

001427

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)

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

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Device Record Status

Public Device Record Key

86580293-77c6-4654-9b55-92cad28ab83a

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Additional Identifiers

Package DI Number

50190752116816

Quantity per Package

1

Contains DI Package

10190752116818

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