None - MALE LUER 20MM VIAL ACCESS DEVICE - CAREFUSION 303, INC.

Duns Number:360624720

Device Description: MALE LUER 20MM VIAL ACCESS DEVICE

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More Product Details

Catalog Number

MV0620

Brand Name

None

Version/Model Number

MV0620

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

LHI

Product Code Name

Set, i.V. Fluid transfer

Device Record Status

Public Device Record Key

b478b2a2-0f3d-4f98-9b40-6f24873fa183

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Additional Identifiers

Package DI Number

50885403232662

Quantity per Package

100

Contains DI Package

10885403232664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAREFUSION 303, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 43