Dover
- Primary DI
- 50192253051610
- Brand
- Dover
- Company
- Cardinal Health 200, LLC
- Model
- 5204
- Catalog number
- 5204
- Device description
- Urine Collection Kit
- Published
- 2024-08-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FCN | Urinary drainage collection kit, for indwelling catheter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50192253051610 | Package | GS1 | 48 | In Commercial Distribution |
| 10192253051612 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 50192253051610 | 50192253051610 |
| 10192253051612 | 10192253051612 |
GMDN Terms
| Term | Definition |
|---|
| Midstream urine specimen container IVD | A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 4.5 | Fluid Ounce |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850063139403 | Neil Medical Group | Neil Medical Group | FCN | 2025-12-08 |
| 00850063139410 | Neil Medical Group | Neil Medical Group | FCN | 2025-12-08 |
| 00850063139427 | Neil Medical Group | Neil Medical Group | FCN | 2025-12-08 |
| 30840330701755 | ProCure | Twin Med, LLC | FCN | 2025-05-31 |
| 30840330701762 | ProCure | Twin Med, LLC | FCN | 2025-05-31 |
| 30840330701779 | ProCure | Twin Med, LLC | FCN | 2025-05-31 |
| 30840330701786 | ProCure | Twin Med, LLC | FCN | 2025-05-31 |
| 50192253027684 | Dover | Cardinal Health 200, LLC | FCN | 2024-10-14 |
| 50192253065488 | Dover | Cardinal Health 200, LLC | FCN | 2024-09-03 |
| 50192253065495 | Dover | Cardinal Health 200, LLC | FCN | 2024-09-03 |
| 50192253065617 | Dover | Cardinal Health 200, LLC | FCN | 2024-09-03 |
| 50192253065624 | Dover | Cardinal Health 200, LLC | FCN | 2024-09-03 |
| 00850053289088 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
| 00850053289095 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
| 00850053289101 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
| 10350770003389 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10350770003396 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10350770003402 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10350770003419 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10350770003426 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10851616002462 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 10851616002561 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 10851616002585 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 50885380176706 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176713 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176720 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176737 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 10851616002028 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
| 10851616002035 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
| 10851616002004 | SteriGear | Sterigear, LLC | FCN | 2020-11-13 |