Bird™ Sentry2 - HIGH FLOW AIR/OXYGEN BLENDER - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: HIGH FLOW AIR/OXYGEN BLENDER

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More Product Details

Catalog Number

30623-002

Brand Name

Bird™ Sentry2

Version/Model Number

30623-002

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

BZR

Product Code Name

Mixer, breathing gases, anesthesia inhalation

Device Record Status

Public Device Record Key

da3a90ef-05e1-48de-be08-78209e2ea85a

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 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