CARDINAL HEALTH - STANDARD VASCULAR ACCESS PACK - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: STANDARD VASCULAR ACCESS PACK

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More Product Details

Catalog Number

SPP99PC1AB

Brand Name

CARDINAL HEALTH

Version/Model Number

SPP99PC1AB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LRO

Product Code Name

General surgery tray

Device Record Status

Public Device Record Key

1f37960d-5b49-4b51-975f-b460004f2ee0

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

November 10, 2016

Additional Identifiers

Package DI Number

50885425483707

Quantity per Package

12

Contains DI Package

10885425483709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 111