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Found 11 results
510(k) Data Aggregation
K Number
K051370Device Name
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
2005-08-12
(78 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.
Device Description
Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.
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K Number
K000265Device Name
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
Manufacturer
PRIMARY CARE SOLUTIONS, INC.
Date Cleared
2001-07-12
(531 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000266Device Name
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
Manufacturer
PRIMARY CARE SOLUTIONS, INC.
Date Cleared
2001-07-12
(531 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003402Device Name
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
Manufacturer
WELCON, INC.
Date Cleared
2001-05-01
(181 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994321Device Name
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
Manufacturer
AUTOMATIC LIQUID PACKAGING, INC.
Date Cleared
2000-10-25
(308 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.
Device Description
Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.
The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.
The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.
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K Number
K974758Device Name
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
Manufacturer
HYDROX LABORATORIES
Date Cleared
1998-03-09
(80 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market.
Device Description
Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle
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K Number
K974759Device Name
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
Manufacturer
HYDROX LABORATORIES
Date Cleared
1998-03-09
(80 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
Device Description
Sterile Saline 0.9% Sodium Chloride Solution
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K Number
K974397Device Name
STERILE SALINE FOR CATHETER CARE
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
1998-02-10
(81 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Baxter Sterile Saline for Catheter Care is intended for use in flushing urinary drainage and suction catheters.
Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.
Device Description
Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares in 250 mL containers.
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K Number
K973734Device Name
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
Manufacturer
WELCON, INC.
Date Cleared
1998-02-05
(128 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sterile water and sterile saline are indicated for device irrigation only.
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
Device Description
The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.
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K Number
K972372Device Name
GERM TRAPPER SUCTION TUBE HOLDER
Manufacturer
RZV MEDICAL SPECIALTIES, INC.
Date Cleared
1997-12-11
(169 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Product Code :
JOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.
Device Description
The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.
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