Identity
- Trade Name
- ABACUS FDA UDI
- Generic Name
- Intravenous solution compounder FDA UDI
- Device Name
- ABACUS Order Entry & Calculation Software versions 3.3.x DE FDA UDI
- Model / Reference
- 83003390 FDA UDI
- Description
- ABACUS Order Entry & Calculation Software versions 3.3.x DE FDA UDI
Identifiers
- Catalog Number
- 83003390 FDA UDI
- Primary DI / UDI-DI
- 05413765577321 FDA UDI
- FDA Product Code
- NEP FDA UDI
- GMDN Term
- Intravenous solution compounder 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous solution compounder
Abacus by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous solution compounder.
- i.v.STATION — HEALTH ROBOTICS SRL · Class II
- PINNACLE® — B. BRAUN MEDICAL INC. · Class II
- PINNACLE® — B. BRAUN MEDICAL INC. · Class II
- APEX™ — B. BRAUN MEDICAL INC. · Class II
- KIRO Fill US — KIRO GRIFOLS SL. · Class II
- APEX® — B. BRAUN MEDICAL INC. · Class II
- APEX® — B. BRAUN MEDICAL INC. · Class II
- IVX Station — Omnicell, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA UDI 8bd75aec-648f-4664-a066-29d80ef9c9e7 36 fields · synced Jun 6, 2026