FDA UDI
In Commercial Distribution
🇺🇸 United States
Dover
DI: 10884521003255
·
Model: 2004LL
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dover
- Primary DI
- 10884521003255
- Version / Model
- 2004LL
- Catalog Number
- 2004LL
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- da337b18-1d1d-4104-8682-d8b00adc35a5
Device Description
100% Silicone Urine Meter Foley Tray,14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Gastroenterology, Urology | 876.5250 | 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 | 20884521003252 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10884521003255 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French | |
| Total Volume | 2000 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT