Supercath 5

GUDID 14543527241677

TOGO MEDIKIT CO.,LTD.

Peripheral vascular catheter

• Primary Device ID: 14543527241677
• NIH Device Record Key: e9ac647b-88ef-413e-ade4-87b32f71af71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Supercath 5
• Version Model Number: SP125-26-19T
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543527241670 [Primary]
GS1	14543527241677 [Package]; Contains: 04543527241670; Package: Box [50 Units]; In Commercial Distribution
GS1	74543527241679 [Package]; Package: Carton [20 Units]; In Commercial Distribution
GS1	84543527241676 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172496
• 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-24

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