DEVICE: S-Cath™ (05055140701190)

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Device Identifier (DI) Information

S-Cath™
5757

MEDIPLUS LTD
05055140701190
GS1
1
S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 14Fr. 10cc, 42cm
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 14.0 French
Length: 42.0 Centimeter
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Device Status

In Commercial Distribution
October 17, 2015

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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
15055140701197 5 05055140701190 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+4401494551200
help@mediplus.co.uk
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