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Needle Guide Assistant

FDA UDI

Class II (US FDA UDI)

by Union Medico Aps

Identity

Trade Name
Needle Guide Assistant FDA UDI
Generic Name
Subcutaneous self-injection aid FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
05714472000004 FDA UDI
510(k) Number
K033696 FDA UDI
FDA Product Code
KZH FDA UDI
GMDN Term
Subcutaneous self-injection aid FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Subcutaneous self-injection aid

Needle Guide Assistant by Union Medico Aps — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous self-injection aid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Union Medico Aps

Sources (1)

  • FDA UDI 963ed286-5c5f-4ced-a691-c513a8cdf206 35 fields · synced Jun 6, 2026