Supercath 5

Basic Information

• Brand Name: Supercath 5
• Primary DI: 04543527235341
• Version / Model: SP205-01
• Company Name: TOGO MEDIKIT CO.,LTD.
• Labeler DUNS: 690724240
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 37560af8-7fbb-460e-828a-34ce39d18262
• Distribution End Date: 2018-01-11

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14543527235348	GS1	Box	50	Not in Commercial Distribution	2016-08-10
Primary	04543527235341	GS1
Package	74543527235340	GS1	Carton	20	Not in Commercial Distribution	2016-08-10

Premarket Submissions

Submission Number	Supplement Number
K140419	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			31 mm Catheter Length
Device Size Text, specify			1.3mm Catheter Diameter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, dark, room-temperature cabinet or closet.
• Type: Storage Environment Humidity
• Temperature Range: High: 75 Percent (%) Relative Humidity