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510(k) Data Aggregation
K Number
K101359Device Name
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2010-08-20
(98 days)
Product Code
FMF, REG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
Device Description
The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body. The piston syringe is a plastic disposable htpodermic syringe made of the following components: - 1 -Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle. - 2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe. - 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger. - 4 Cap - Covers the cannula/needle until the syringe is to be used. The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
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K Number
K092413Device Name
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2009-09-04
(28 days)
Product Code
MEG, REG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
Device Description
The Inviro Medical InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. The InviroSnap Insulin Safety Syringe is designed to aid in the prevention of needle stick injuries.
The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:
- Barrel
- Plunger
- O-Ring
- Stopper
- Hub Assembly
- Cannula
- Locking Ring
- Cap
After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.
The InviroSnap insulin Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.
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K Number
K092430Device Name
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2009-09-04
(28 days)
Product Code
MEG, REG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
Device Description
The Inviro Medical InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries. The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components: Barrel, Plunger, O-Ring, Stopper, Luer Assembly, Cannula, Locking Ring, Cap. After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container. The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.
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K Number
K083851Device Name
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2009-05-15
(142 days)
Product Code
LHI, REG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
Device Description
The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites. The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. The InviroBlunt Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.
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K Number
K081436Device Name
INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2008-10-22
(154 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.
Device Description
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
The piston syringe is a plastic disposable htpodermic syringe made of the following components:
- 1 Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
- 2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe.
- 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
- 4 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 5 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
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K Number
K071307Device Name
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2008-02-12
(279 days)
Product Code
FMI, LHI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
Device Description
The InviroLink/InviroTip Plastic Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.
The family of InviroLink Plastic Cannulas are 18 gauge equivalent plastic cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroLink Plastic Cannulas:
1. InviroLink, Model # 130001
2. InviroLink with EZ wings, Model # 130501
The InviroLink Plastic Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.
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K Number
K070203Device Name
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2007-04-23
(91 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INVIRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
Device Description
The Inviro Medical InviroSnap Safety Syringe is used to inject medicines and vaccines into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:
- l Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
- 2 Plunger - After using the syringe, the plunger is retracted and snapped off leaving the needle in the barrel of the syringe.
- 3 O-Ring - The O-ring minimizes the risk of leakage around the Adapter.
- Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
- Adapter The Adapter facilitates passage of the fluid 5 between the cannula and the barrel. In addition, the cannula/needle is bonded to the Adapter.
- 6 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 7 Cap - Covers the cannula/needle until the syringe is to be used.
After use, the health care professional fully depresses the plunger to engage the Adapter Needle assembly. Once the Adapter Needle Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.
The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
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