FDA UDI
In Commercial Distribution
🇺🇸 United States
PureWick
DI: 00801741226984
·
Model: PWFXH30
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- PureWick
- Primary DI
- 00801741226984
- Version / Model
- PWFXH30
- Catalog Number
- PWFXH30
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 1
- Public Version Date
- 2024-08-06
- Public Version Status
- New
- Public Device Record Key
- a5205653-5365-48de-924d-0a3acbe1d6d5
Device Description
PureWick Flex Female External Catheter, Home Care
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- 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
- 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 |
|---|---|---|---|---|
| 61157 | Female wearable urinal, single-use | A non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741226981 | GS1 | CA | 30 | In Commercial Distribution | |
| Primary | 00801741226984 | GS1 | ||||
| Package | 20801741226988 | GS1 | BX | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]