Nexus TKO®

GUDID 30815879021046

Nexus TKO®-6P Anti-Reflux Luer Activated Device

NEXUS MEDICAL, LLC

Neutral-pressure intravenous line needleless valve-connector

• Primary Device ID: 30815879021046
• NIH Device Record Key: 4c56998b-4a87-4a52-905d-6c8b4c570654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexus TKO®
• Version Model Number: BB4650
• Company DUNS: 169260325
• Company Name: NEXUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 1-866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 1-866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815879021042 [Primary]
GS1	30815879021046 [Package]; Contains: 10815879021042; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130416

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-19
• Device Publish Date: 2018-06-11

On-Brand Devices [Nexus TKO®]

• 30892855000998: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Nexus TKO®-6P Rotating Luer & Pinc
• 30892855000844: 11" Microbore Extension Set with Nexus TKO®-6P, Rotating Luer & Slide Clamp
• 30892855000837: 11" Arterial Standardbore Extension Set with (1) Nexus TKO®-6P Two-Way Valve
• 30892855000738: 15" Microbore Extension Set with Nexus TKO®-6PHV & Pinch Clamp
• 30892855000721: Nexus TKO®-6PHV Hi-Visibility Anti-Reflux Luer Activated Device
• 30892855000707: 6" Microbore Extension Set with Nexus TKO®-6P, Slip Luer & Slide Clamp
• 30892855000691: 15" Microbore Extension Set with Non-Bonded Nexus TKO®-6P, Rotating Luer & Pinch Clamp
• 30892855000684: 6" Bifurcated Microbore Extension Set with (2) Nexus TKO®-6P, Rotating Luer & Slide Clamp
• 30892855000677: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Nexus TKO®-6P, Rotating Luer & Sli
• 30892855000660: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotating
• 30892855000653: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotating
• 30892855000646: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotat
• 30892855000639: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotat
• 30892855000578: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Nexus TKO®-6P, Rotating Luer & Sli
• 30892855000561: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Nexus TKO®-6P, Rotating Luer &
• 30892855000547: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotating
• 30892855000530: 6" Microbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotating
• 30892855000523: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotat
• 10892855000512: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded Nexus TKO®-6P, Rotat
• 30892855000509: Nexus TKO®-6P Anti-Reflux Luer Activated Device
• 30892855000028: Nexus TKO®-5 Anti-Reflux Split Septum Device
• 30892855000011: Nexus TKO®-4S Anti-Reflux Luer Lock Device
• 30815879021213: 7" Microbore Extension Set with Non-Bonded Nexus TKO®-6PHV, Rotating Luer & Pinch Clamp
• 10815879021202: 15" Microbore Extension Set with Nexus TKO®-6PHV & Pinch Clamp
• 30815879021237: 4" Trifurcated Extension Set with Nexus TKO®-6P, Rotating Luer & Slide Clamps
• 30815879021046: Nexus TKO®-6P Anti-Reflux Luer Activated Device
• 30815879021275: 60" Minibore Extension Set with Nexus TKO®-6P & Slide Clamp