DEVICE: SpeediCath Standard (05708932020336)
Device Identifier (DI) Information
SpeediCath Standard
28482
In Commercial Distribution
28482
Coloplast A/S
28482
In Commercial Distribution
28482
Coloplast A/S
Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
45605 | Single-administration urethral catheterization kit, single-use |
A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBM | CATHETER, URETHRAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from sunlight. Do not use if package is damaged and consult IFU. |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 10 French |
Catheter Working Length: 35 Centimeter |
Device Size Text, specify: Tip Type Straight/Nelaton |
Catheter Working Length: 13.9 Inch |
Device Record Status
534c99b4-1ee3-415d-9e60-0dda8d1c665e
April 18, 2024
5
September 02, 2016
April 18, 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 |
---|---|---|---|---|---|
05708932640817 | 100 | 05708932020336 | In Commercial Distribution | Shipper Box |
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
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com