Nexus TKO®

GUDID 30815879021466

Nexus TKO®-6PHV Hi-Visibility Anti-Reflux Luer Activated Device

NEXUS MEDICAL, LLC

Neutral-pressure intravenous line needleless valve-connector

• Primary Device ID: 30815879021466
• NIH Device Record Key: fa8685b5-45e7-47cd-a627-e5f339eccc7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexus TKO®
• Version Model Number: BB4650HV
• 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
• 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
• 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	10815879021462 [Primary]
GS1	30815879021466 [Package]; Contains: 10815879021462; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-24
• Device Publish Date: 2021-08-16

On-Brand Devices [ Nexus TKO®]

• 30815879021336: 60" Ultra-Microbore Extension Set with Nexus TKO®-6P, .22 Micron Filter, Rotating Luer & Slide
• 30815879021305: 60" Minibore Extension Set with Nexus TKO®-6P, 1.2 Micron Filter, Rotating Luer & Slide Clamp
• 30815879021329: 4" Trifurcated Minibore Extension Set with (2) Nexus TKO®-6P and (1) Nexus TKO®-6P One-Way Val
• 30815879021312: 4" Bifurcated Minibore Extension Set with (1) Nexus TKO®-6P and (1) Nexus TKO®-6P One-Way Valv
• 30815879021374: 6" Bifurcated Standardbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded (2) Nexus
• 30815879021367: 6" Bifurcated Microbore Pressure-Rated (max 325 psi) Extension Set with Non-Bonded (2) Nexus TKO
• 30815879021350: 6" Bifurcated Standardbore Pressure-Rated (max 325 psi) Extension Set with (2) Nexus TKO®-6P, R
• 30815879021435: 6" Split Septum T-Site Extension Set with Non-Bonded Nexus TKO®-6P, Rotating Luer & Pinch Clam
• 30815879021459: 4" Trifurcated Extension Set with Nexus TKO®-6P One-Way Valves, Rotating Luer & Slide Clamps
• 30815879021503: 15" Microbore Extension Set with Nexus TKO®-6P, Rotating Luer & Pinch Clamp
• 30815879021497: 15" Microbore Extension Set with Non-Bonded Nexus TKO®-6P, Rotating Luer & Pinch Clamp
• 30815879021480: 15" Microbore Extension Set with Nexus TKO®-6PHV & Pinch Clamp
• 30815879021473: 15" Microbore Extension Set with Non-Bonded Nexus TKO®-6PHV & Pinch Clamp
• 30815879021466: Nexus TKO®-6PHV Hi-Visibility Anti-Reflux Luer Activated Device
• 30815879021510: 4” Quadfurcate Extension Set with (3X) TKO-6P One-Way, (1X) TKO-6P Two-Way, Rotating Luer and
• 30815879021534: 6" Trifurcated Extension Set with (1) Nexus TKO®-6P T-Site and (3) Nexus TKO®-6P One-Way Valve
• 30815879021589: 6" TKO-6P T-Site Extension Set with 2-way TKO-6P and Purple Slide Clamp
• 30815879021626: 9" Hexfurcated Extension Set with (1) Nexus TKO®-6P T-Site and (6) Nexus TKO®-6P One-Way Valve
• 30815879021633: 6" TKO-6P T-Site Extension Set with White Slide Clamp
• 30815879021640: 7" Hexfurcated Extension Set with (6) Nexus TKO®-6P One-Way Valve, Rotating Luer & Slide Clamps
• 30815879021671: Quadfurcated Extension Set with Nexus TKO®-6P, 60” Ultramicrobore Leg and 40” Spike Leg wit
• 30815879021794: Quadfurcated Extension Set with Nexus TKO®-6P, 60” Ultramicrobore Leg and Dual Check Valve wi
• 30815879021800: Closed System ANTT Kit
• 30815879021817: 7-inch Hepfurcated Extension Set with Nexus TKO-6P One-Ways, Rotating Luer and Slide Clamps