DEVICE: Urocare® Thumb Tube Clamp, Two-Position (00792293070005)

Device Identifier (DI) Information

Urocare® Thumb Tube Clamp, Two-Position
7000
In Commercial Distribution
7000
UROCARE PRODUCTS, INC.
00792293070005
GS1

1
070637129 *Terms of Use
CLAMP, TUBE, URINE COLLECTION, TWO-POSITION, REUSABLE, WHITE Features: 2 Position—Open or Closed. Maximum Tube Size O.D: 0.46"
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
45376 Penis/scrotum wearable urinal
A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable 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
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
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
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Width: 0.73 Inch
Weight: 0.01 Pound
Length: 1.63 Inch
Height: 0.81 Inch
CLOSE

Device Record Status

7c27f75b-66af-4c29-a7bd-51e0672504eb
May 10, 2021
8
April 11, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20792293070009 50 00792293070005 In Commercial Distribution Case
10792293070002 10 00792293070005 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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