FDA UDI
In Commercial Distribution
🇺🇸 United States
PureWick Urine Collection System
DI: 00801741185342
·
Model: PW100
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PureWick Urine Collection System
- Primary DI
- 00801741185342
- Version / Model
- PW100
- Catalog Number
- PW100
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2024-08-19
- Public Version Status
- Update
- Public Device Record Key
- cf81ab18-9c77-4630-96e5-ba249abebdf3
Device Description
PureWick Urine Collection System Kit, Non-Battery
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NZU | Collector, urine, powered, non indwelling catheter | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60917 | Bed incontinence system | An assembly of devices intended to be fitted to a home bed and used by an incontinent/bed-bound patient for the removal of excrement and subsequent washing during bed occupancy. It includes a mains electricity (AC-powered) air/water pumping unit with heated water reservoir; waste container; and controls connected via relevant tubing to a suction cup, which conforms to the patient’s perineum. It may also include a bed washing/suction hose for general body cleaning, and a shaped mattress to accommodate the system tubing. Waste (i.e., faeces, urine, and waste water) is intended to be removed through suction; a supply of water and air is used to clean and dry the patient after waste removal. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741185342 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal