DEVICE: SpeediCath Flex Coude (05708932643573)
Device Identifier (DI) Information
SpeediCath Flex Coude
28920
Not in Commercial Distribution
28920
Coloplast A/S
28920
Not in Commercial Distribution
28920
Coloplast A/S
Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
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? |
---|---|---|---|---|
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBM | CATHETER, URETHRAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 10 French |
Length: 44 Centimeter |
Outer Diameter: 3.3 Millimeter |
Device Size Text, specify: Male |
Length: 17.32 Inch |
Device Record Status
390b2892-a1e7-417b-9f8d-63b5425aabfd
June 19, 2020
4
November 04, 2016
June 19, 2020
4
November 04, 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 |
---|---|---|---|---|---|
05708932643672 | 3 | 05708932017220 | 2020-06-18 | Not in Commercial Distribution | shipper box |
05708932017220 | 30 | 05708932643573 | 2020-06-18 | Not in Commercial Distribution | retail box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com