DEVICE: SpeediCath (05708932020398)

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Device Identifier (DI) Information

SpeediCath
28492
28492
Coloplast A/S
05708932020398
GS1
1
SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Tiemann. Male. FR 12/4.0 mm. Rx only.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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
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.
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FDA Product Code

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Product Code Product Code Name
GBM CATHETER, URETHRAL
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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
Special Storage Condition, Specify: Do not use if sterile barrier is damaged
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 12 French
Length: 40 Centimeter
Outer Diameter: 4 Millimeter
Device Size Text, specify: Male
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Device Status

In Commercial Distribution
September 02, 2016

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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
05708932640923 30 05708932020398 In Commercial Distribution Retail box
05708932640930 10 05708932640923 In Commercial Distribution Shipper box
05708932024808 5 05708932020398 In Commercial Distribution Sample pack
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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
No
No CLOSE

Customer Contact

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