Identity
- Trade Name
- PureWick FDA UDI
- Generic Name
- Female wearable urinal, single-use FDA UDI
- Device Name
- PureWick Flex Female External Catheter, Home Care FDA UDI
- Model / Reference
- PWFXH30 FDA UDI
- Description
- PureWick Flex Female External Catheter, Home Care FDA UDI
Identifiers
- Catalog Number
- PWFXH30 FDA UDI
- Primary DI / UDI-DI
- 00801741226984 FDA UDI
- FDA Product Code
- NZU FDA UDI
- GMDN Term
- Female wearable urinal, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Female wearable urinal, single-use
PureWick by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female wearable urinal, single-use.
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- BOEHRINGER® CareDry™ System — BOEHRINGER LABORATORIES, LLC · Class I
- Hollister — Hollister Incorporated · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- PureWick Female External Catheter — C. R. Bard, Inc. · Class I
- PureWick Female External Catheter — C. R. Bard, Inc. · Class I
- PureWick Female External Catheter — C. R. Bard, Inc. · Class I
- PureWick Female External Catheter — C. R. Bard, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI a5205653-5365-48de-924d-0a3acbe1d6d5 35 fields · synced Jun 8, 2026