DEVICE: Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" (00792293060617)

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Device Record History
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Device Identifier (DI) Information
Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"
6061
In Commercial Distribution
6061
UROCARE PRODUCTS, INC.
00792293060617
GS1

1
070637129 *Terms of Use
TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE Features “Reverse-Grip” technology and graduated barbs to provide a secure hold on most standard sized drainage or extension tubing. May be used to connect 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. DEHP-Free, Latex-Free and Sterile (EO). Nozzle adapter and cap are preassembled.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
Yes
No
No
No

GMDN

[?]

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?
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
40504 Hand-held urinal, reusable
A portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a reusable device.
Active false
58923 Wearable adult urine collection bag, open-ended
A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NNX Device, Incontinence, Urosheath Type, Non-Sterile
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
FAQ Bag, Urine Collection, Leg, For External Use, Sterile
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 0.28 Inch
Outer Diameter: 0.39 Inch
Weight: 0.18 Pound
Length: 60.00 Inch
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Device Record Status
2a7b0240-7dde-44b8-87e6-160fc6e4e75d
May 10, 2021
8
April 11, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10792293060614 50 00792293060617 In Commercial Distribution Case
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
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