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SureStep™ Foley Tray System Bardex® IC Complete Care®
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SureStep™ Foley Tray System Bardex® IC Complete Care® FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- SureStep™ Foley Tray System|Bardex® IC Complete Care®|Temperature Sensing Foley Catheter Tray & 350 ml Urine Meter FDA UDI
- Model / Reference
- A919418AM FDA UDI
- Description
- SureStep™ Foley Tray System|Bardex® IC Complete Care®|Temperature Sensing Foley Catheter Tray & 350 ml Urine Meter FDA UDI
Identifiers
- Catalog Number
- A919418AM FDA UDI
- Primary DI / UDI-DI
- 00801741104794 FDA UDI
- FDA Product Code
- MJC FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Dimensions & Sizes
- Size
- Catheter Gauge — 18 French FDA UDI
SureStep™ Foley Tray System Bardex® IC Complete Care® by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 1add40f3-3ea4-47d1-ae86-523f3f678eb7 37 fields · synced May 31, 2026