DEVICE: Urocare® Pliable White-Rubber Drainage Tubing, Medium 0.28" I.D. x 10 ft. (00792293608284)

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Device Identifier (DI) Information
Urocare® Pliable White-Rubber Drainage Tubing, Medium 0.28" I.D. x 10 ft.
600828
In Commercial Distribution
600828
UROCARE PRODUCTS, INC.
00792293608284
GS1

1
070637129 *Terms of Use
TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER, MALE, EXTERNAL, CATHETER, REUSABLE Tubing may be easily cut to desired length and used as an extension between Uro-Con® or Uro-Cath® male external catheters, Foley® indwelling catheters and reusable or disposable urinary drainage bags, bottles or other urinary and ostomy appliances. Provides a snug fit on most standard sized drainage ports/outlets while resisting kinks.
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Device Characteristics
Labeling does not contain MRI Safety Information
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Yes
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Yes
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GMDN

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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?
34929 Urinary incontinence penis sheath/port, single-use
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
Active false
58924 Open-ended wearable urine collection bag, non-sterile
A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.
Obsolete false
58921 Non-wearable adult urine collection bag, open-ended
A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
NNX Device, Incontinence, Urosheath Type, Non-Sterile
FAQ Bag, Urine Collection, Leg, For External Use, Sterile
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
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
Length: 10 Feet
Outer Diameter: 0.34 Inch
Weight: 0.20 Pound
Lumen/Inner Diameter: 0.28 Inch
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Device Record Status
909f0abd-25dd-4716-9f8f-ea78831b5a40
June 10, 2022
5
May 30, 2018
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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