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510(k) Data Aggregation
K Number
K183444Device Name
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
Manufacturer
Cenorin, LLC
Date Cleared
2019-09-09
(271 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Product Code :
LDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cenorin 610 and Cenorin 610HT Washer-Pasteurizer/High Level Disinfectors are intended for cleaning and high level disinfection of semi-critical and non-critical medical devices using thermal disinfection by full immersion pasteurization.
Device Description
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K Number
K031799Device Name
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
Manufacturer
MIELE, INC.
Date Cleared
2003-11-12
(155 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Product Code :
LDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:
Device Description
The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueous cleaning and simultaneous thermal disinfection of dental instruments and accessories. It operates with three spray arms on three different levels. A powerful circulation pump moves 2.8 gallons of water at a rate of 105 gallons/minute. The specially designed jets on the spray arms spray the water onto the wash load at a low pressure (About 13 psi) to prevent any goods from being washed off the racks.
The complete unit is made of electro-polished stainless steel, the exterior is additionally powder coated. The unit is equipped with a microcomputer control. An integrated water softener ensures consistently high water quality; the steam condenser comes standard and minimizes contaminated aerosols and odor affecting the environment.
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K Number
K983068Device Name
RELIANCE FAMILY OF WASHER-DISINFECTORS
Manufacturer
STERIS Corporation
Date Cleared
2000-05-31
(637 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Product Code :
LDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STERIS Amsco Reliance Family of Washer / Disinfectors are indicated for use in the cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid instruments such as forceps and clamp, and other similar and related articles found in healthcare facilities.
Device Description
The Amsco Reliance Family of Washer/Disinfectors are mechanical, computercontrolled Washer/Disinfectors. They are designed with pre-programmed cycles intended specifically for surgical instruments, delicate instrumentation (gentle cycle), utensils, glassware, plastic goods, anesthesia/respiratory goods and equipment decontamination. Additional cycles are available for customized programming to meet specific operating requirements.
Essentially, the Amsco Reliance Family of Washer/Disinfectors operate as follows: the load items are placed in the chamber where they are exposed to pressurized fluids delivered through a circulation system driven by a pump and controlled by a programmable computer. Injection pumps allow the automatic delivery of the selected chemicals in the sump water. Available configurations include steam or electrical heating of the sump water; and the drying option (electrically heated on some models. steam heated on others). The cabinet, chamber, and circulation system (including the pump) are primarily constructed of stainless steel.
The available cycle phases can be summarized as follows:
- 1. cold tap water pre-wash for the removal of gross soil;
- soaking in an enzymatic solution to break down proteinaceous materials; 2.
- 3. detergent wash to complete the soil removal:
- sonic cleaning to remove fine debris in crevices:
- hot tap water rinse to remove detergent and soil residues:
- thermal rinse to disinfect the load items;
- 7. pure water rinse and instrument lubrication:
- 8. drvina.
Note: Phases 2 and 4 are not offered on all models. Phases 2, 4, 7 and 8 are optional features.
The available accessories include a variety of single and multi-level loading racks, and transfer carts. Some models offer conveyor systems used to automate the loading of racks into the chamber, to initiate the proper cycle by reading a bar code tag located on the loading rack, and to provide queuing capacity.
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K Number
K972193Device Name
OLYMPIX MINI-PASTEURMATIC (58210)
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1997-09-05
(87 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Product Code :
LDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.
Device Description
The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters.
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K Number
K950518Device Name
MIELE G 7781 DENTAL THERMAL DISINFECTOR
Manufacturer
MIELE PROFESSIONAL
Date Cleared
1996-01-26
(354 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Product Code :
LDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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