Supercath 5

GUDID 14543527242551

TOGO MEDIKIT CO.,LTD.

Peripheral vascular infusion catheter
Primary Device ID14543527242551
NIH Device Record Key884add23-fd71-4d5c-ba88-833538e53f62
Commercial Distribution StatusIn Commercial Distribution
Brand NameSupercath 5
Version Model NumberSP120-20-31T
Company DUNS690724240
Company NameTOGO MEDIKIT CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment HumidityBetween 0 and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104543527242554 [Primary]
GS114543527242551 [Package]
Contains: 04543527242554
Package: Box [50 Units]
In Commercial Distribution
GS184543527242550 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-16
Device Publish Date2018-02-09

On-Brand Devices [Supercath 5]

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

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