DEVICE: Supercath 5 (04543527235280)

Device Identifier (DI) Information

Supercath 5
SP206-01
Not in Commercial Distribution

TOGO MEDIKIT CO.,LTD.
04543527235280
GS1
January 11, 2018
1
690724240 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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.
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FDA Product Code

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

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 31 mm Catheter Length
Device Size Text, specify: 1.1mm Catheter Diameter
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Device Record Status

ad080ea1-9585-40a2-b5d7-cf92108b2f91
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
74543527235289 20 14543527235287 2017-07-19 Not in Commercial Distribution Carton
14543527235287 50 04543527235280 2017-07-19 Not in Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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