DEVICE: Supercath 5 (04543527242561)

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Device Record History
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Device Identifier (DI) Information
Supercath 5
SP120-22-31T
In Commercial Distribution

TOGO MEDIKIT CO.,LTD.
04543527242561
GS1

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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status
9cf935d2-2a53-4228-8ff4-d8c382cf8293
April 15, 2024
6
February 09, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14543527242568 50 04543527242561 In Commercial Distribution Box
84543527242567 4 14543527242568 In Commercial Distribution Carton
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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)

[?]
No
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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