DEVICE: SpeediCath Standard (05708932020589)
Device Identifier (DI) Information
SpeediCath Standard
28706
In Commercial Distribution
28706
Coloplast A/S
28706
In Commercial Distribution
28706
Coloplast A/S
SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Pediatric. FR 6/2.0 mm. Rx only.
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. Do not use if package is damaged and consult IFU. |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 6 French |
Device Size Text, specify: Tip Type Straight/Nelaton |
Catheter Working Length: 16 Centimeter |
Catheter Working Length: 6.3 Inch |
Device Record Status
823480ee-893a-48fc-8652-8d7a7b2eefe3
March 19, 2024
5
September 02, 2016
March 19, 2024
5
September 02, 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 |
---|---|---|---|---|---|
05708932640497 | 30 | 05708932020589 | In Commercial Distribution | Retail Box | |
05708932640503 | 10 | 05708932640497 | In Commercial Distribution | Shipper 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