Identity
- Trade Name
- BD® Alaris™ Pump Module, Model 8100 FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Device Name
- BD Alaris™ Pump Module, Model 8100 v12.1.2 FDA UDI
- Model / Reference
- 8100 FDA UDI
- Description
- BD Alaris™ Pump Module, Model 8100 v12.1.2 FDA UDI
Identifiers
- Catalog Number
- 8100BDBDXEN1212 FDA UDI
- Primary DI / UDI-DI
- 10885403810046 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Bedside infusion pump, single-channel
BD® Alaris™ Pump Module, Model 8100 by CareFusion 303, INC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- CareFusion 303, INC
Sources (1)
- FDA UDI 6f9cf8d5-71e2-48b9-b463-59d35863272f 36 fields · synced Jun 6, 2026