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510(k) Data Aggregation
K Number
K152522Device Name
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
Manufacturer
ECOLAB, INC.
Date Cleared
2016-01-15
(134 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
ECOLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush®machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or cold solution is required.
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.
Device Description
The ORS Fluid Warming and Slush Drapes are sterile, single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. The ORS Fluid Warming drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warming consoles. The ORS Surgical Slush drapes consist of a polyurethane film base secured to a polycarbonate disc or plate manufactured to protect ORS surgical slush machines from contamination during various procedures throughout the clinical setting.
The ORS Fluid Warming and Slush Drapes come in a variety of sizes and shapes specifically designed for safe use and proper fit on ORS Fluid Warming Consoles and Slush Machines.
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K Number
K142173Device Name
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
Manufacturer
ECOLAB, INC.
Date Cleared
2014-12-30
(145 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
ECOLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
The following model(s) are included: ORS-400 and ORS-400N
Device Description
The ORS-400N Scope Pillow™ Warmer Drape is a single-use disposable device provided non-sterile to secondary processors, who then package, label and sterilize the device. The Scope Pillow Warmer Drape is an accessory/equipment drape for use with the ORS-2057 Irrigation Solution Warming System which is designed to both protect ORS surgical fluid warmers from contamination during various procedures as well as hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
The drape material is the identical polyurethane film that is used on all standard ORS Warmer Drapes (K021288). A soft polyurethane foam pillow is integrated within the polyurethane drape and has no direct or indirect patient contact. The pillow (endoscope holder) is designed to provide stable positioning of scope(s) during warming and prevents one or more scopes from rolling or tipping while the scope rests in the fluid warmer during the procedure (Figure 5-1).
The ORS-400 and ORS-400N model drapes are identical with the exception of how they are packaged and labeled. The ORS-400 model consists of drapes individually packaged in labeled peel pouches or header bags which are stacked inside a double poly-lined corrugate case with Instructions for Use (IFU) insert and sterilized by an Ecolab subcontractor before it is released for sale. The ORS-400N model consists of the identical drapes which are individually wrapped in a poly tie secured by a product ID label and stacked inside a double poly-lined corrugate case with IFU insert that does not get sterilized before it is released for sale to kit packer customers. The IFU insert differs between the two models in that the ORS-400N contains sterilization instructions for kit packer customers to evaluate their sterilization process as it applies to placing the product in their commercial procedure kits.
NOTE: Both device models are designed and intended to be used by clinical staff in sterile condition.
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K Number
K142080Device Name
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
Manufacturer
ECOLAB, INC.
Date Cleared
2014-08-28
(28 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
ECOLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS drape is a single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
Device Description
The Non-Sterile ORS Warming and Slush Drapes are single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. These equipment drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warmers and slush machines from contamination during various procedures throughout the clinical setting.
These equipment drapes come in a variety of sizes and shapes to allow the device to properly fit ORS surgical fluid warmers and slush machines.
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