Catalog Number

SBA48PPAD1

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA48PPAD1

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

-

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

2fb13e21-b59e-49a8-bcf7-00dc49b8ac3f

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Package DI Number

50195594943651

Quantity per Package

4

Contains DI Package

10195594943653

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE