FDA UDI
In Commercial Distribution
🇺🇸 United States
Urocare® Top Adapter for Urinary Drainage Bottle
DI: 00792293060037
·
Model: 6003
·
UROCARE PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Urocare® Top Adapter for Urinary Drainage Bottle
- Primary DI
- 00792293060037
- Version / Model
- 6003
- Catalog Number
- 6003
- 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
- 4
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 10dc1906-d555-4909-9305-d6759a9c917b
Device Description
ADAPTER, TOP, URINE COLLECTION, OSTOMY, BOTTLE, STANDARD, REUSABLE, REPLACEMENT Replacement Top Adapter for Urocare Urinary Drainage Bottles #4100, #4101 and #4140.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10792293060034 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00792293060037 | GS1 |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.01 | Pound | |
| Height | 1.24 | Inch | |
| Outer Diameter | 0.84 | Inch |