TRUEplus S5002B31-100

GUDID 50096295129101

LEADER TRUEplus Pen Needles 31 GAUGE x 3/16"

TRIVIDIA HEALTH, INC.

Autoinjector needle

• Primary Device ID: 50096295129101
• NIH Device Record Key: 365b1fdc-25b9-4557-a8f0-5719d05e894b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUEplus
• Version Model Number: TRUEplus Pen Needles 31 GAUGE x 3/16"
• Catalog Number: S5002B31-100
• Company DUNS: 151810868
• Company Name: TRIVIDIA HEALTH, INC.
• Device Count: 100
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)803-6025
• Email: customercare@trividiahealth.com

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292008994 [Unit of Use]
GS1	00096295129106 [Primary]
GS1	50096295129101 [Package]; Contains: 00096295129106; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143437

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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