Monoject - Blood Collection Tube,Glycerine Coated Lavender - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Blood Collection Tube,Glycerine Coated Lavender Stopper, EDTA (K3) 0.04 mL 15.0% Solution, Blood Collection Tube,Glycerine Coated Lavender Stopper, EDTA (K3) 0.04 mL 15.0% Solution, 4.0 mL Draw

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More Product Details

Catalog Number

8881311347

Brand Name

Monoject

Version/Model Number

8881311347

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K771052,K771052,K771052

Product Code Details

Product Code

GIM

Product Code Name

Tubes, vacuum sample, with anticoagulant

Device Record Status

Public Device Record Key

9880e847-b56f-4250-8a9f-edfe1c72df91

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521150093

Quantity per Package

1000

Contains DI Package

30884521150090

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