FDA UDI
In Commercial Distribution
🇺🇸 United States
Dover
DI: 10192253028423
·
Model: 8000
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dover
- Primary DI
- 10192253028423
- Version / Model
- 8000
- Catalog Number
- 8000-
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 1
- Public Version Date
- 2025-04-09
- Public Version Status
- New
- Public Device Record Key
- 6b4eb44f-fc73-4ce0-82b9-83f68d1bf36c
Device Description
URINE DRAINAGE BAG WITH 200 ML URINE METER, NEEDLE SAMPLING, DRAIN TUBE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FFG | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE | Gastroenterology, Urology | 876.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32072 | Urine flowmeter, single-use | A non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253028421 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10192253028423 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 200 | Milliliter |