Supercath 5

GUDID 74543527241624

TOGO MEDIKIT CO.,LTD.

Peripheral vascular catheter
Primary Device ID74543527241624
NIH Device Record Keyff51b622-0fb6-4754-a338-1230c223c66c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSupercath 5
Version Model NumberSP120-16-31-WT
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104543527241625 [Primary]
GS114543527241622 [Package]
Contains: 04543527241625
Package: Box [50 Units]
In Commercial Distribution
GS174543527241624 [Package]
Contains: 14543527241622
Package: Carton [20 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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-24

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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