MAJ
COMMUNICATION CABLE 1.8M - MAJ-1948
Device Description
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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: FCX
Device Name: Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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: 876.1500
Third Party Flag: Y
Medical Specialty: GU
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 Identifiers
Device Id: 04953170305023
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
