Identity
- Trade Name
- Alaris, SmartSite FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Pump Infusion Set, Back Check Valve, 4 Y-Sites, 395 cm (156 in) FDA UDI
- Model / Reference
- 2435-0007 FDA UDI
- Description
- Pump Infusion Set, Back Check Valve, 4 Y-Sites, 395 cm (156 in) FDA UDI
Identifiers
- Catalog Number
- 2435-0007 FDA UDI
- Primary DI / UDI-DI
- 10885403220906 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
No
FDA UDI
Combination Product
No
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
Dimensions & Sizes
- Size
- Length — 156 Inch FDA UDI
Category: Electric infusion pump administration set, single-use
Alaris, SmartSite by BD Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric infusion pump administration set, single-use.
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- CADD — ICU MEDICAL, INC. · Class II
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC · Class II
- Infusomat® — B. BRAUN MEDICAL INC. · Class II
- Curlin Administration Set — ZEVEX INTERNATIONAL, 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
- BD Switzerland Sàrl
Sources (1)
- FDA UDI 18e04426-07fc-4f11-a3b9-560adf45fb24 37 fields · synced May 30, 2026