MAJ
Cylinder hose with switch-over valve (Pin-index) - MAJ-1985
Device Description
A collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HIF
Device Name: Insufflator, Laparoscopic
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 884.1730
Third Party Flag: N
Medical Specialty: OB
Code: OSV
Device Name: Insufflator, Endoscopic Vessel Harvesting
Device Class: 2
Physical State: An electronic software controlled gas insufflator which can accept CO2 gas from either a tank or central wall supply. The gas flow rate and pressure can be adjusted by the user.
Definition: To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The insufflator delivers CO2 gas at a controlled flow rate and pressure to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Leg, saphenous vein or arm, radial artery
Regulation Number: 884.1730
Third Party Flag: N
Medical Specialty: OB
Device IdentifiersDevice Id: 04953170324208
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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