DEVICE: SpeediCath (05708932020459)

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Device Identifier (DI) Information

SpeediCath
28502
28502
Coloplast A/S
05708932020459
GS1
1
SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, sterilized using irradiation. FR 12/4.0 mm. 1 Water proof drape, sterilized using ethylene oxide. 2 Non-latex gloves, sterilized using ethylene oxide. 2 Non-sterile iodine pads. Rx only.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

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.
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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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
Outer Diameter: 4 Millimeter
Device Size Text, specify: Female
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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
05708932641036 100 05708932020459 In Commercial Distribution Shipper box
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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