TRUEplus S5H01C31-100

GUDID 10021292009059

TRUEplus STERILE pen needles 31 GAUGE x 1/4"

TRIVIDIA HEALTH, INC.

Autoinjector needle

• Primary Device ID: 10021292009059
• NIH Device Record Key: e6a342d7-f3a5-4a33-af43-aa818f84a443
• Commercial Distribution Discontinuation: 2020-02-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRUEplus
• Version Model Number: TRUEplus STERILE pen needles 31 GAUGE x 1/4"
• Catalog Number: S5H01C31-100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292009007 [Unit of Use]
GS1	00021292009052 [Primary]
GS1	10021292009059 [Package]; Contains: 00021292009052; Package: Case [30 Units]; Discontinued: 2020-02-14; Not 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: 4
• Public Version Date: 2020-04-09
• Device Publish Date: 2016-09-22

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