Identity
- Trade Name
- Hollister FDA UDI
- Generic Name
- Female wearable urinal, single-use FDA UDI
- Device Name
- Female Urinary Pouch, SoftFlex FDA UDI
- Model / Reference
- 9840 FDA UDI
- Description
- Female Urinary Pouch, SoftFlex FDA UDI
Identifiers
- Catalog Number
- 9840 FDA UDI
- Primary DI / UDI-DI
- 00610075055982 FDA UDI
- FDA Product Code
- NOA 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
Dimensions & Sizes
- Size
- Length — 19 Centimeter FDA UDI
Category: Female wearable urinal, single-use
Hollister by Hollister Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female wearable urinal, single-use.
- BOEHRINGER® CareDry™ System — BOEHRINGER LABORATORIES, LLC · 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
- PureWick — C. R. Bard, Inc. · Class I
- PureWick Female External Catheter — C. R. Bard, Inc. · Class I
- PureWick — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hollister Incorporated
Sources (1)
- FDA UDI 8a2ebeac-7e3c-43d1-ad9b-832fa5abc8bd 36 fields · synced Jun 9, 2026