FK20200E - 6” (15.25cm Minibore/smallbore extension set with - PATHEN MEDICAL LLC

Duns Number:042928915

Device Description: 6” (15.25cm Minibore/smallbore extension set with slide clamp, male luer lock with non-bon 6” (15.25cm Minibore/smallbore extension set with slide clamp, male luer lock with non-bonded needle-free connector

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More Product Details

Catalog Number

-

Brand Name

FK20200E

Version/Model Number

FK20200E

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

e31db36d-5a16-4b49-9201-b8f92be55c46

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Additional Identifiers

Package DI Number

10850005864124

Quantity per Package

100

Contains DI Package

00850005864127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PATHEN MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 45