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510(k) Data Aggregation
K Number
K193250Device Name
Irrigation Tubing with CO2 or Air
Manufacturer
KeyMed (Medical and Industrial Equipment) Ltd.
Date Cleared
2020-04-06
(133 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**KeyMed (Medical **and Industrial Equipment) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
Device Description
The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
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K Number
K122818Device Name
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
Manufacturer
OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT
Date Cleared
2013-01-04
(112 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS **KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT) LT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows:
ETO Sterilization .. . .. 100% ETO concentration: 735 mg/L Temp: 57 °C -------------Relative Humidity: 70% Processing (Hold) Time: 1 hour Aeration Time: 12 hours
Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temp: 135 °C Exposure Time: 3 minutes Drving Time: 20 minutes
Device Description
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a polymer tray with a perforated lid intended to secure an endoscope and accessories during exposure to gaseous sterilization methods.
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K Number
K100899Device Name
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
Manufacturer
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
Date Cleared
2010-09-13
(166 days)
Product Code
FEQ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.
Device Description
The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope.
The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected.
The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button.
The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.
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K Number
K011725Device Name
OLYMPUS SUCTION PUMP, MODEL KV-5
Manufacturer
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
Date Cleared
2001-08-31
(88 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
**KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
Device Description
Not Found
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K Number
K000948Device Name
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
Manufacturer
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
Date Cleared
2000-05-12
(50 days)
Product Code
FEQ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962528Device Name
OLYMPUS MOBILE CHAIR/COUCH
Manufacturer
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
Date Cleared
1996-12-12
(168 days)
Product Code
FZK
Regulation Number
878.4950Why did this record match?
Applicant Name (Manufacturer) :
**KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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