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510(k) Data Aggregation
K Number
K020500Device Name
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
2002-03-19
(33 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
UNIVEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.
Device Description
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.
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K Number
K993996Device Name
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
2000-07-17
(236 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
UNIVEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.
Device Description
Not Found
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K Number
K000747Device Name
UNIVEC TWO PIECE SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
2000-06-08
(93 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
UNIVEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961877Device Name
PISTON SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
1996-08-07
(89 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
UNIVEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectible medications.
Device Description
The UNIVEC Nonreusable Syringe with Coupling Assembly provides a single use function. This assembly, inserted between the syringe plunger and the syringe rubber stopper, will decouple the plunger from the stopper (and disable the syringe) after injecting one dosage of serum. The assembly materials will be fabricated from the same polypropylene as the syringe.
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K Number
K933469Device Name
UNIVEC NON-REUSABLE SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
1996-04-18
(1007 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
UNIVEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
Device Description
The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella.
Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.
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