DEVICE: Silicone Supra-Pubic Catheter (Integrated Balloon) (04710961937531)
Device Identifier (DI) Information
Silicone Supra-Pubic Catheter (Integrated Balloon)
4890-0210
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
4890-0210
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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34924 | Suprapubic drainage catheter |
A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KOB | Catheter, Suprapubic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K014002 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
41b18b08-7acd-4b16-b2f4-20692975e43a
July 06, 2018
3
March 15, 2016
July 06, 2018
3
March 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
14710961937538
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined