FDA UDI
In Commercial Distribution
🇺🇸 United States
Dover
DI: 10884521016644
·
Model: 2826
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dover
- Primary DI
- 10884521016644
- Version / Model
- 2826
- Catalog Number
- 2826
- 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
- 8
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 09c2b616-7d16-4568-baec-25d447e51e6e
- Distribution End Date
- 2025-12-31
Device Description
Hydrogel Coated Latex Foley Catheter,30 mL, 3-Way
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KOD | CATHETER, UROLOGICAL | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34930 | Single-administration urethral drainage/irrigation catheter | A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30884521016648 | GS1 | PACK_OR_INNER_PACK | 12 | In Commercial Distribution | 2025-12-31 |
| Primary | 10884521016644 | GS1 | ||||
| Package | 20884521016641 | GS1 | CASE | 120 | In Commercial Distribution | 2025-12-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 30 | Milliliter | |
| Catheter Gauge | 26 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This Side Up;