Supercath 5

Basic Information

• Brand Name: Supercath 5
• Primary DI: 04543527245708
• Version / Model: SP125-22-25-WT
• Company Name: TOGO MEDIKIT CO.,LTD.
• Labeler DUNS: 690724240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: a79e64c5-aa7a-4afe-b218-691fec538b0f

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: No
• 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
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14543527245705	GS1	Box	50	In Commercial Distribution
Primary	04543527245708	GS1
Package	84543527238928	GS1	Carton	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K190001	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.7mm Catheter Diameter
Device Size Text, specify			14 mm Catheter Length

Storage Conditions

• 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
• Type: Storage Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit