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.
7000
In Commercial Distribution
7000
UROCARE PRODUCTS, INC.
CLAMP, TUBE, URINE COLLECTION, TWO-POSITION, REUSABLE, WHITE
Features:
2 Position—Open or Closed.
Maximum Tube Size O.D: 0.46"
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 |
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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 0.73 Inch |
Weight: 0.01 Pound |
Length: 1.63 Inch |
Height: 0.81 Inch |
Device Record Status
7c27f75b-66af-4c29-a7bd-51e0672504eb
May 10, 2021
8
April 11, 2018
May 10, 2021
8
April 11, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
CUST.SUPPORT@UROCARE.COM