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Found 5 results
510(k) Data Aggregation
K Number
K242291Device Name
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
Manufacturer
Sol-Millennium Medical Inc.
Date Cleared
2024-11-20
(110 days)
Product Code
QNQ
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Sol-Millennium Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
Device Description
The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
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K Number
K242099Device Name
Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
Manufacturer
Sol-Millennium Medical Inc.
Date Cleared
2024-10-22
(96 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Sol-Millennium Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.
Device Description
The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL.
The proposed device includes different specifications:
1ml Slip Tip Syringe without Needle
3ml Slip Tip Syringe without Needle
5ml Slip Tip Syringe without Needle
10ml Slip Tip Syringe without Needle
20ml Slip Tip Syringe without Needle
30ml Slip Tip Syringe without Needle
60ml Slip Tip Syringe without Needle
10ml Eccentric Tip Syringe without Needle
20ml Eccentric Tip Syringe without Needle
60ml Eccentric Tip Syringe without Needle
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K Number
K241821Device Name
Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
Manufacturer
Sol-Millennium Medical Inc.
Date Cleared
2024-09-20
(88 days)
Product Code
FMF, FMI, MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Sol-Millennium Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.
The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.
Device Description
The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.
The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.
The proposed devices are offered in various gauge sizes and length.
The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
The device is for medical professionals use only and for prescription use only.
- Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.
- Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").
- Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").
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K Number
K220713Device Name
Sol-Guard Auto-disable Syringe
Manufacturer
Sol-Millennium Medical Inc.
Date Cleared
2023-05-04
(419 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Sol-Millennium Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse.
Device Description
The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids.
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K Number
K222744Device Name
Sol-M Luer Lock Syringe
Manufacturer
Sol-Millennium Medical Inc.
Date Cleared
2022-10-11
(29 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Sol-Millennium Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sol-M Luer Lock Syringe is intended for aspiration of medications and fluids into the body.
Device Description
The Sol-M Luer Lock Syringe is used to aspirate and inject fluid/medication into the body. The syringe is a sterile, single-use, 3-part syringe with luer lock conical connection. The Sol-MTM Luer Lock Syringe consists of the following components: Barrel, Plunger, Gasket. In addition to being used manually, the Sol-MTM Luer Lock Syringe can also work with a powerdriven syringe pump, with the luer lock tip connected to the IV administration line to deliver specific volume of fluid/medication. The syringe is individually blister packaged, and EtO sterilized with SAL of 10-6. The Sol-M™ Luer Lock Syringe is provided in 1, 3, 5, 10, 20, 30, and 60ml volume.
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