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510(k) Data Aggregation
K Number
K242434Device Name
Insulin Syringes
Manufacturer
CHIRANA T. Injecta
Date Cleared
2024-12-24
(130 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
CHIRANA T. Injecta
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
Device Description
The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
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K Number
K220614Device Name
MEDOJECT fine Pen Needles
Manufacturer
Chirana T. Injecta
Date Cleared
2022-06-15
(104 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Chirana T. Injecta
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K201044Device Name
CHIRANA Insulin Syringes
Manufacturer
CHIRANA T. Injecta
Date Cleared
2022-01-18
(637 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
CHIRANA T. Injecta
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
Device Description
The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
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K Number
K201009Device Name
CHIRAVAC Blood Collection Needles
Manufacturer
CHIRANA T. Injecta
Date Cleared
2021-07-21
(460 days)
Product Code
JKA, FMI
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
CHIRANA T. Injecta
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
Device Description
The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.
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