FDA UDI
In Commercial Distribution
🇺🇸 United States
Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"
DI: 00792293060600
·
Model: 6060
·
UROCARE PRODUCTS, INC.
Product Codes
4
GMDN Terms
4
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"
- Primary DI
- 00792293060600
- Version / Model
- 6060
- Catalog Number
- 6060
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-11
- Public Version
- 8
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 89ee7a0c-7ce8-4d55-be03-617162086e73
Device Description
TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE, STERILE 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00792293060600 | GS1 | ||||
| Package | 10792293060607 | GS1 | Case | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60.00 | Inch | |
| Weight | 0.18 | Pound | |
| Outer Diameter | 0.39 | Inch | |
| Lumen/Inner Diameter | 0.28 | Inch |