DEVICE: FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 12CH (05055788710561)

Device Identifier (DI) Information

FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 12CH
03-51012U
In Commercial Distribution

FLEXICARE MEDICAL LIMITED
05055788710561
GS1

1
504406273 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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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
Urine-sampling urethral catheter A sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KOD Catheter, Urological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132619 000
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

217bf96e-8579-4264-8e7b-0053dcb524d9
July 06, 2018
3
October 04, 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
No Package DIs found
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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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No Customer Contact currently defined
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