ANTIFOG SOLUTION KIT, ENDOSCOP
McKesson - 19-1001
Device Description
A liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OCT
Device Name: Anti Fog Solution And Accessories, Endoscopy
Device Class: 2
Physical State: anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution
Definition: To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Apply solution to lens, typically by spraying or wiping.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: endoscopic lens
Regulation Number: 876.1500
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 20612479156948
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
Device Id: 40612479156959
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479156948
Package Quantity: 48
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case