IV Plus®

GUDID 30815879020896

22 Ga. X 0.50 in. (0.7 mm X 13 mm)

STAR MOUNTAIN MEDICAL TECHNOLOGIES, INC.

Vascular port administration set

• Primary Device ID: 30815879020896
• NIH Device Record Key: 1f96514b-3aed-4b0a-93ad-5c8fcd7a6661
• Commercial Distribution Discontinuation: 2019-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IV Plus®
• Version Model Number: HS05022
• Company DUNS: 080490186
• Company Name: STAR MOUNTAIN MEDICAL TECHNOLOGIES, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815879020892 [Primary]
GS1	30815879020896 [Package]; Contains: 10815879020892; Package: [25 Units]; Discontinued: 2019-08-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142590

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: 7
• Public Version Date: 2020-02-26
• Device Publish Date: 2016-11-10

On-Brand Devices [IV Plus®]

• 30815879020988: 22 Ga. X 1.50 in. (0.7 mm X 38 mm)
• 30815879020971: 20 Ga. X 1.50 in. (0.9 mm X 38 mm)
• 30815879020964: 19 Ga. X 1.50 in. (1.1 mm X 38 mm)
• 30815879020957: 22 Ga. X 1.00 in. (0.7 mm X 25 mm)
• 30815879020940: 20 Ga. X 1.00 in. (0.9 mm X 25 mm)
• 30815879020933: 19 Ga. X 1.00 in. (1.1 mm X 25 mm)
• 30815978020926: 22 Ga. X 0.75 in. (0.7 mm X 19 mm)
• 30815879020919: 20 Ga. X 0.75 in. (0.9 mm X 19 mm)
• 30815879020902: 19 Ga. X 0.75 in. (1.1 mm X 19 mm)
• 30815879020896: 22 Ga. X 0.50 in. (0.7 mm X 13 mm)
• 30815879020889: 20 Ga. X 0.50 in. (0.9 mm X 13 mm)
• 30815879020872: 19 Ga. X 0.50 in. (1.1 mm X 13 mm)