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510(k) Data Aggregation
K Number
K051019Device Name
SAFETY NEEDLE
Manufacturer
SARSTEDT, INC.
Date Cleared
2005-07-25
(94 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
SARSTEDT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.
The Safety-Needle is intended to be used in all hospitals and/or practices where S-Monovettes are used.
Device Description
The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.
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K Number
K031359Device Name
S-MONOVETTE EDTA K2-GEL
Manufacturer
SARSTEDT, INC.
Date Cleared
2003-09-12
(135 days)
Product Code
PJE
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
SARSTEDT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.
The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.
Device Description
Not Found
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K Number
K032150Device Name
SAFETY-MULTIFLY
Manufacturer
SARSTEDT, INC.
Date Cleared
2003-09-12
(60 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SARSTEDT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.
The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.
Device Description
The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector.
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K Number
K024237Device Name
URINE MONOVETTE BORIC ACID
Manufacturer
SARSTEDT, INC.
Date Cleared
2003-04-14
(112 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
SARSTEDT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis
Device Description
Urine Monovette® boric acid
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K Number
K003382Device Name
SARSTEDT NEEDLE PROTECTOR
Manufacturer
SARSTEDT, INC.
Date Cleared
2001-03-30
(150 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SARSTEDT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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