Nexus TKO® - 60" Minibore Extension Set with Nexus TKO®-6P, - NEXUS MEDICAL, LLC

Duns Number:169260325

Device Description: 60" Minibore Extension Set with Nexus TKO®-6P, 1.2 Micron Filter, Rotating Luer & Slide Cl 60" Minibore Extension Set with Nexus TKO®-6P, 1.2 Micron Filter, Rotating Luer & Slide Clamp

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More Product Details

Catalog Number

-

Brand Name

Nexus TKO®

Version/Model Number

PTB4883

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

2a530d0d-f347-4334-90dc-0b15bf0af5ea

Public Version Date

December 03, 2020

Public Version Number

1

DI Record Publish Date

November 25, 2020

Additional Identifiers

Package DI Number

30815879021305

Quantity per Package

100

Contains DI Package

10815879021301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NEXUS MEDICAL, LLC" 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. 180