Dover
- Primary DI
- 20884521029658
- Brand
- Dover
- Company
- Cardinal Health, Inc.
- Model
- PA16ULP
- Catalog number
- PA16ULP
- Device description
- Advantage Hydrogel Coated Latex Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- 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 |
|---|
| 20884521029658 | Package | GS1 | 10 | In Commercial Distribution |
| 10884521029651 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20884521029658 | 20884521029658 |
| 10884521029651 | 10884521029651 |
GMDN Terms
| Term | Definition |
|---|
| Indwelling urethral catheterization kit, adult | A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Catheter Gauge | 16 | French |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep Dry;AVOID DIRECT SUNLIGHT |
Regulatory Flags
- DUNS number
- 080935429
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| 00850063139403 | Neil Medical Group | Neil Medical Group | FCN | 2025-12-08 |
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| 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 |
| 50192253051610 | Dover | Cardinal Health 200, LLC | FCN | 2024-08-08 |
| 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 |
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