DEVICE: Self-Cath Plus (05708932999540)

Device Identifier (DI) Information

Self-Cath Plus
50495 / 4418
In Commercial Distribution
50495 / 4418
Coloplast A/S
05708932999540
GS1

1
305524696 *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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45603 Single-administration urethral drainage catheter
A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003784 000
K221401 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged and consult IFU.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 18 French
Device Size Text, specify: Tip Type Straight/Nelaton
Catheter Working Length: 14.9 Inch
Catheter Working Length: 38 Centimeter
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Device Record Status

1d469e0f-b6f1-4cca-9178-e473e841ce4b
October 03, 2023
5
September 22, 2016
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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
05708932279802 12 05708932279796 In Commercial Distribution Shipper Box
05708932279796 30 05708932999540 In Commercial Distribution Retail Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
+1(800)533-0464
healthcarecs@coloplast.com
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