IV Catheter - Merit Pharmaceutical

Duns Number:093370369

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More Product Details

Catalog Number

-

Brand Name

IV Catheter

Version/Model Number

035662588000

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

-

Product Code Details

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device Record Status

Public Device Record Key

38d83f19-6789-45e6-ba14-7af78ed3f42c

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Additional Identifiers

Package DI Number

10853620005187

Quantity per Package

50

Contains DI Package

00853620005180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERIT PHARMACEUTICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 23