Health Mart/UltiCare

GUDID 30357515905414

8mm Pen Needle UltiGuard

ULTIMED, INC.

Autoinjector needle Autoinjector needle

• Primary Device ID: 30357515905414
• NIH Device Record Key: 02762dfc-09a4-4ace-9305-783061fea55e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Mart/UltiCare
• Version Model Number: 2790541
• Company DUNS: 024723541
• Company Name: ULTIMED, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515710055 [Unit of Use]
GS1	20357515905417 [Primary]
GS1	30357515905414 [Package]; Contains: 20357515905417; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100812

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2018-12-03
• Device Publish Date: 2018-11-01

On-Brand Devices [Health Mart/UltiCare]

• 30357515905414: 8mm Pen Needle UltiGuard
• 30357515904677: 6mm Pen Needle UltiGuard
• 30357515902444: 4mm Pen Needle UltiGuard