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Dose Iq Safety Software
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref DOSEIQW0001
Identity
- Trade Name
- DOSE IQ SAFETY SOFTWARE EUDAMEDFDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Device Name
- Dose IQ Safety Software EUDAMEDInfusion Safety Management Software FDA UDI
- Model / Reference
- DOSEIQW0001 EUDAMED1.9 FDA UDI
- Description
- Infusion Safety Management Software FDA UDI
Identifiers
- Catalog Number
- DOSEIQW0001 FDA UDI
- Primary DI / UDI-DI
- 20085412676610 EUDAMEDFDA UDI
- Basic UDI-DI
- 00854120000000000000048JE EUDAMED
- FDA Product Code
- PHC FDA UDI
- EMDN Code
- Z12030382 INFUSION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Infusion pump medication-dosage application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dose Iq Safety Software by Baxter Healthcare SA — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230665 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K211124 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 00854120000000000000048JE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare SA
- EUDAMED SRN
- CH-MF-000026124
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (3)
- EUDAMED 1573b42b-9a19-4989-b63c-690a5e4aef82 61 fields · synced Jul 11, 2026
- FDA UDI 5b781c06-4182-47ea-8d65-8b0fec75db05 35 fields · synced May 30, 2026
- FDA 510(k) K230665 1 fields · synced May 18, 2026