EXEL Injection Plug with Cap - Injection Plug with Cap, Luer Lock - Exel International

Duns Number:180572216

Device Description: Injection Plug with Cap, Luer Lock

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More Product Details

Catalog Number

26539

Brand Name

EXEL Injection Plug with Cap

Version/Model Number

26539

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

7d2676d5-cef6-481f-9b30-cc8b050b1ccb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

20020221265396

Quantity per Package

4

Contains DI Package

10020221265399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"EXEL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 82