DEVICE: S-Cath™ (05055140701190)
Device Identifier (DI) Information
S-Cath™
5757
In Commercial Distribution
MEDIPLUS LTD
5757
In Commercial Distribution
MEDIPLUS LTD
S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 14Fr. 10cc, 42cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
---|---|---|---|---|
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 |
---|---|
KOB | CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132890 | 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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Catheter Gauge: 14.0 French |
Length: 42.0 Centimeter |
Device Record Status
8a438f5d-c5d2-406e-9208-6876674bd944
July 06, 2018
3
October 17, 2015
July 06, 2018
3
October 17, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15055140701197 | 5 | 05055140701190 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401494551200
help@mediplus.co.uk
help@mediplus.co.uk