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510(k) Data Aggregation
K Number
K213407Device Name
UltiCare Disposable Pen Needles
Manufacturer
Date Cleared
2021-12-16
(58 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
UltiMed Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.
Device Description
The UltiCare™ Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. 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 are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (5/32" to 1/2").
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K Number
K140949Device Name
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
Manufacturer
Date Cleared
2015-02-09
(301 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ULTIMED INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UltiCare™ Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries.
Device Description
The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is a standard piston type syringe with a removable needle and protective shield. This sterile, single-use, disposable 3 ml piston syringes consist of a syringe barrel, plunger rod with gasket, removable single lumen needle, needle cap, and protective shield. The UltiCare Safety Syringes are non-toxic and non-pyrogenic, and will be available in a range of needle gauges and lengths between the smallest (27G x 5/16") and the largest (21G x 1 1/2").
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