Catalog Number

-

Brand Name

22MM FLEXTUBE BREATHING SYSTEM WITH 2L BAG, ELBOW AND LIMB, 1.6M

Version/Model Number

2010000

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

c91988cb-978c-4063-b751-e4e30d07ed9d

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 25, 2021

Package DI Number

05030267144044

Quantity per Package

14

Contains DI Package

05030267059539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-