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510(k) Data Aggregation
K Number
K050464Device Name
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
Manufacturer
ULTI MED, INC.
Date Cleared
2005-05-11
(77 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ULTI MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Device Description
The UltiCare Disposable Pen Needles are sterile, single-use, type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and nonpyrogenic, and are available in a variety of needle sizes (29 gauge to 31 gauge) and lengths (3/16" to 1/2").
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K Number
K021983Device Name
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
Manufacturer
ULTI MED, INC.
Date Cleared
2002-09-16
(90 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ULTI MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin syringes in the home. After use the syringes are to be deposited into the container for safe storage and eventual disposal according to local regulations.
Device Description
The Ulti Guard Home syringe contains 100 UltiCare insulin syringes. Syringes can be selectively removed as needed, and used syringes conveniently deposited back into the top of the container for safe storage. Ulti Guard syringes and container are single use only.
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