Precision - Urine Specimen System with Preservative - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Urine Specimen System with Preservative

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More Product Details

Catalog Number

7000SA

Brand Name

Precision

Version/Model Number

7000SA

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMH

Product Code Name

Container, Specimen, Sterile

Device Record Status

Public Device Record Key

a3d3a85e-0aef-48fd-915e-e2240bc2dad1

Public Version Date

February 23, 2021

Public Version Number

3

DI Record Publish Date

June 30, 2018

Additional Identifiers

Package DI Number

40884527005957

Quantity per Package

200

Contains DI Package

20884521151861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17