DEVICE: Ch24 round silicone catheter (M640R99000990011)

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Device Record History
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Device Identifier (DI) Information
Ch24 round silicone catheter
001
In Commercial Distribution
R9900099
RAND SPA
M640R99000990011
HIBCC

1
655010531 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
47796 Multi-purpose percutaneous abdominothoracic drainage catheter
A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GBX Catheter, Irrigation
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 600 Millimeter
Catheter Gauge: 24 French
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Device Record Status
fde83105-138f-47d1-93c8-7c2c5b447bf1
June 22, 2022
3
April 20, 2020
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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
M640R99000990012 10 M640R99000990011 In Commercial Distribution Unit of sale box
M640R99000990013 4 M640R99000990012 2022-04-08 Not in Commercial Distribution Shipping box
M640R99000990014 2 M640R99000990012 2022-04-08 Not in Commercial Distribution Shipping 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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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