Needle Guide Assistant

Primary DI
05714472000004
Brand
Needle Guide Assistant
Company
Union Medico ApS
Model
1
Device 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.
Published
2025-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033696000PERSONAL INJECTORUnion Medico Aps2005-02-16KZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714472000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714472000004057144720000045714472000004

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous self-injection aidA device designed to be used by a layperson to self-administer a subcutaneous injection, typically by a person who has difficulty with painless self-injections [e.g., patients with rheumatoid arthritis (RA)]. It is typically in the form of a tube or container in which a prefilled syringe assembly (syringe with medication and needle) is placed and secured; the user grips the device, places it on the body surface at the injection site, and presses the plunger of the syringe to inject the medication. The device may also enable needle penetration at an appropriate angle (typically 90° to the body surface) and to a pre-set depth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4570266010customerservice@unionmedico.com

Regulatory Flags#

DUNS number
305456134
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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