Catalog Number

-

Brand Name

22MM COMPACT BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, FILTER AND LIMB, 2M

Version/Model Number

2153000

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

Yes

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

7390301f-b470-406b-bb88-b4f6a3ce8df9

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 14, 2021

Package DI Number

05030267123841

Quantity per Package

35

Contains DI Package

05030267063406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-