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SLS 550i
EUDAMEDFDA UDIClass I (EU MDR)
Ref SLS550iModel Safe Label System Point of Care
Identity
- Trade Name
- SLS 550i EUDAMEDCodonics Safe Label System®(SLS) 550i Point of Care Station FDA UDI
- Generic Name
- Parenteral-nutrition management software FDA UDI
- Device Name
- SLS 500i EUDAMEDIntegrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items FDA UDI
- Model / Reference
- Safe Label System Point of Care EUDAMEDSLS550i EUDAMED550i PCS FDA UDI
- Description
- Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905020366 EUDAMEDFDA UDI
- Basic UDI-DI
- 081490502SLSPCS01XR EUDAMED
- Direct Marketing DI
- 00814905020366 EUDAMED
- 510(k) Number
- K101439 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Parenteral-nutrition management software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SLS 550i by Codonics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081490502SLSPCS01XR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Codonics Inc.
- EUDAMED SRN
- US-MF-000008190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 8790f7db-60ec-4de1-b510-94fced561ce7 61 fields · synced Aug 1, 2026
- FDA UDI 74356074-ca47-45e9-bf18-d2089f76b6c2 35 fields · synced May 30, 2026