Search Results
Found 7 results
510(k) Data Aggregation
K Number
K090502Device Name
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2009-03-10
(13 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K090122Device Name
NUOVOGUARD
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2009-02-05
(15 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations
Device Description
Not Found
Ask a Question
K Number
K083454Device Name
NUOVOCATH
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2008-12-04
(13 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NUOVOcath IV Catheter in size 14G to 26 G is used for venous access for the infusion of I.V. fluids, medicines into the circulating system.
Device Description
NUOVOCATH IV CATHETER
Ask a Question
K Number
K080660Device Name
IV ADMINISTRATION SET
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2008-05-13
(64 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Device Description
The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.
Ask a Question
K Number
K080665Device Name
NOVOLET
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2008-05-13
(64 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Novolet Scalp Vein Blood Collection Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Device Description
Not Found
Ask a Question
K Number
K003381Device Name
SHIELDING NEEDLE HOLDER
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2001-04-23
(174 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990831Device Name
SUPERGUARD SAFETY SYRINGE
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2000-03-08
(362 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
U.S. SAFETY SYRINGES CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.
Device Description
The SuperGuard ™ Safety Syringe is a piston syringe combined with a sharps Injury Prevention mechanism that shields the hypodermic needle from exposure and reuse after an initial use.
Ask a Question
Page 1 of 1