Catalog Number

-

Brand Name

SMOOTHBORE BREATHING SYSTEM LIMB 0.5M

Version/Model Number

5005000

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

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

89d70f5c-9eeb-4950-8552-80c52ff967d0

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2021

Package DI Number

05030267028566

Quantity per Package

50

Contains DI Package

05030267068319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-