Catalog Number

10011A

Brand Name

BIRD™

Version/Model Number

10011A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K883038

Product Code

BZR

Product Code Name

Mixer, breathing gases, anesthesia inhalation

Public Device Record Key

5d43c365-f63a-49a7-a7d3-56fdd4aace34

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-