IV Plus

GUDID 30815879021664

Non-Vented Vial Access Spike

NEXUS MEDICAL, LLC

Fluid transfer set, general-purpose

• Primary Device ID: 30815879021664
• NIH Device Record Key: 2bb1f8de-055b-4f72-a82f-4b8a27d7191c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Plus
• Version Model Number: N0640
• 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: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM
• Phone: 866-336-3987
• Email: TKOCUSTSERV@NEXUSMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815879021660 [Primary]
GS1	30815879021664 [Package]; Contains: 10815879021660; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080976

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2024-03-13
• Device Publish Date: 2024-03-05

On-Brand Devices [IV Plus]

• 10815879021240: 60” Minibore Extension Set with Non-Removable Slide Clamp
• 30815879021282: 144" Ultra-Microbore Extension Set with Green Stripe
• 30815879021299: 48" TPN Air Transfer Set
• 30815879021398: Non-Vented Bag Spike with NIS-6P
• 30815879021381: Blunt Cannula in Blister Pack
• 30815879021411: 8" Standardbore Extension Set with 1.2 Micron Filter and Slide Clamp
• 30815879021428: NMT8046
• 30815879021442: 4" Trifurcated Extension Set with Rotating Luer & Slide Clamps
• 30815879021404: 8" Standardbore Extension Set with 0.2 Micron Filter & Slide Clamp
• 30815879021527: 60" Closed System with Medication Spike Leg and 0.22 Micron Filter
• 30815879021541: Mini Vented Transfer Pin with Nexus NIS®-6P
• 30815879021558: 144" Microbore Extension Set
• 30815879021565: Trifurcated Extension Set with (1) Nexus NIS®-6P, 0.22-micron Filter and 60" Stopcock Leg with
• 30815879021572: 6 in Microbore Extension Set with Split Septum Mini T-site and Non-Removable Red Slide Clamp
• 30815879021596: Blood Sampling Trifurcate with Bonded Blunt Cannula
• 30815879021602: 15" Microbore Extension Set with Non-Bonded Nexus NIS®-6P & Pinch Clamp
• 30815879021619: 60" Ultra-Microbore Extension Set with Nexus NIS®-6P, Rotating Luer & Slide Clamp
• 30815879021657: 60" Ultra-Microbore Extension Set & Slide Clamp
• 30815879021664: Non-Vented Vial Access Spike
• 30815879021688: 80" Ultra-Microbore Extension Set with 0.22 Micron Filter & Slide Clamps
• 30815879021695: 105 inch Administration Tubing Set with 20 Drop Drip Chamber, Roller Clamp and Luer Activated Y
• 30815879021718: 80” Ultra-Microbore Extension Set with 0.22 Micron Filter & Low Volume Needleless Connector
• 30815879021770: 4-Way Stopcock with Vented Caps
• 30815879021763: 3-Way Stopcock with Vented Caps
• 30815879021701: 3-Way Stopcock with Vented Caps
• 30815879021725: Bag Access Device with Texium Valve
• 30815879021756: 25 mm Syringe Filter 0.2 µm Supor™
• 30815879021749: 25 mm Syringe Filter 0.2 µm Supor™ with Female Connector and Vented Caps
• 30815879021787: 60” Closed System with Medication Spike Leg and NIS-6P
• 30815879021855: 60-inch Ultramicrobore Set with Bonded Nexus NIS-LV
• 30815879021848: 15-inch Microbore Transfer Set with Green Pinch Clamp
• 30815879021831: 15-inch Microbore Transfer Set with Two Male Luer Locks