AccessGUDID - DEVICE: Supercath 5 (04543527235372)

GUDID

Device Identifier (DI) Information

Brand Name: Supercath 5
Version or Model: SP201-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TOGO MEDIKIT CO.,LTD.

Primary DI Number: 04543527235372
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 690724240 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140419	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 25 mm Catheter Length
Device Size Text, specify: 0.9mm Catheter Diameter

Device Record Status

Public Device Record Key: 701007aa-d59d-4047-aca6-af0fe77d314f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016