DEVICE: Lumax TS Pro (00088937011173)

Device Identifier (DI) Information

Lumax TS Pro
10307-010
In Commercial Distribution

Coopersurgical, Inc.
00088937011173
GS1

1
801895244 *Terms of Use
Fiberoptic Pressure Transducer Catheter: Bladder, 10 French
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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
Urodynamic catheter A long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FEN Device, Cystometric, Hydraulic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K953734 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

ee0b36d0-4a53-44f1-bc39-cec27a835116
July 06, 2018
3
May 09, 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
20888937011177 10 00088937011173 In Commercial Distribution
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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