Supercath 5

GUDID 84543527245704

TOGO MEDIKIT CO.,LTD.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 84543527245704
• NIH Device Record Key: 13b3cc48-c720-47cf-be19-dd8f3bfeffad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Supercath 5
• Version Model Number: SP125-24-14T
• Company DUNS: 690724240
• Company Name: TOGO MEDIKIT CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.

Device Identifiers

Device Issuing Agency	Device ID
GS1	84543527245704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190001

FDA Product Code

• FOZ: Catheter, intravascular, therapeutic, short-term less than 30 days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

On-Brand Devices [Supercath 5]

• 14543527243121: SP120-20-25-WT
• 74543527243116: SP120-20-25T
• 74543527242652: SP120-24-19-WT
• 14543527242643: SP120-22-25-WT
• 14543527242636: SP120-22-31-WT
• 14543527242629: SP120-20-31-WT
• 14543527242612: SP120-18-31-WT
• 14543527242605: SP125-16-31-WT
• 14543527242599: SP125-14-31-WT
• 14543527242582: SP120-24-19T
• 14543527242575: SP120-22-25T
• 74543527242560: SP120-22-31T
• 74543527242553: SP120-20-31T
• 74543527242546: SP120-18-31T
• 14543527242537: SP125-16-31T
• 14543527242520: SP125-14-31T
• 14543527241677: SP125-26-19T
• 74543527241662: SP120-20-50-WT
• 14543527241653: SP120-18-50-WT
• 74543527241648: SP120-20-50T
• 74543527241631: SP120-18-50T
• 74543527241624: SP120-16-31-WT
• 74543527241617: SP120-16-31T
• 74543527237221: SP125-24-19-WT
• 14543527237212: SP125-24-19T
• 74543527235388: SP209-01
• 74543527235371: SP201-01
• 14543527235362: SP203-01
• 74543527235357: SP207-01
• 14543527235348: SP205-01
• 74543527235333: SP211-01
• 74543527235326: SP213-01
• 14543527235317: SP208-01
• 14543527235300: SP200-01
• 74543527235296: SP202-01
• 74543527235289: SP206-01
• 14543527235270: SP204-01
• 74543527235265: SP210-01
• 74543527235258: SP212-01
• 14543527245729: SP125-26-19-WT
• 14543527245712: SP125-26-14-WT
• 14543527245705: SP125-22-25-WT
• 14543527237229: SP125-22-25T
• 14543527243114: SP120-20-25T
• 84543527245704: SP125-24-14T
• 14543527242650: SP120-24-19-WT
• 14543527242544: SP120-18-31T
• 14543527241660: SP120-20-50-WT
• 14543527242568: SP120-22-31T
• 14543527242551: SP120-20-31T