Identity
- Trade Name
- BioFlo FDA UDI
- Generic Name
- Urethral/suprapubic catheter valve-connector FDA UDI
- Device Name
- BioFlo AutoValve Urine Valve FDA UDI
- Model / Reference
- AU17 FDA UDI
- Description
- BioFlo AutoValve Urine Valve FDA UDI
Identifiers
- Primary DI / UDI-DI
- B567AU170 FDA UDI
- FDA Product Code
- FCN FDA UDI
- GMDN Term
- Urethral/suprapubic catheter valve-connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Urethral/suprapubic catheter valve-connector
BioFlo by Insert Molding Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral/suprapubic catheter valve-connector.
- Bard® Ureteral Catheter Adapter — C. R. Bard, Inc. · Class II
- Goldberg — COOK INCORPORATED · Class II
- Bard® Flip-Flo™ Catheter Valve — C. R. Bard, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Bard® Adapter and Tubing — C. R. Bard, Inc. · Class II
- Bard® Flip-Flo™ Catheter Valve — C. R. Bard, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Insert Molding Solutions, Inc.
Sources (1)
- FDA UDI 9f65ac46-43c7-49ae-a764-5b567b759434 33 fields · synced May 30, 2026