Catalog Number

34-5770B

Brand Name

CARDINAL HEALTH

Version/Model Number

34-5770B

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

OFQ

Product Code Name

Anesthesia kit

Public Device Record Key

fe3f3549-e5ee-4e22-bfdf-1d1676f0e455

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

50195594945860

Quantity per Package

17

Contains DI Package

10195594945862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE