Needle Guide Assistant

GUDID 05714472000004

The Device is intended to allow patients or carers to self-administer inject able FDA approved drugs or biologics with a safe, simple and easy injection system. Personal Injector is intended to be used in any setting including the home. Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance. surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting. Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections. and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort. Personal Injector two unique Syringe-I lolders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin. apomorphine, and many others medications.

Union Medico ApS

Subcutaneous self-injection aid

• Primary Device ID: 05714472000004
• NIH Device Record Key: 963ed286-5c5f-4ced-a691-c513a8cdf206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Guide Assistant
• Version Model Number: 1
• Company DUNS: 305456134
• Company Name: Union Medico ApS
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com
• Phone: +4570266010
• Email: customerservice@unionmedico.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714472000004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033696

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-13
• Device Publish Date: 2025-05-05