Catalog Number

SPPV1PPFS2

Brand Name

CARDINAL HEALTH

Version/Model Number

SPPV1PPFS2

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

c1420a88-69d9-490c-9eb8-9ddc4cd10728

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

Package DI Number

50195594412829

Quantity per Package

20

Contains DI Package

10195594412821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE