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Codonics Safe Label System®(SLS) 500i Point of Care Station
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Codonics Safe Label System®(SLS) 500i Point of Care Station FDA UDI
- Generic Name
- Parenteral-nutrition management software FDA UDI
- Device Name
- Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-142C FDA UDI
- Model / Reference
- 500i PCS -142C FDA UDI
- Description
- Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-142C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905020250 FDA UDI
- 510(k) Number
- K101439 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Parenteral-nutrition management software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Parenteral-nutrition management software
Codonics Safe Label System®(SLS) 500i Point of Care Station by Codonics Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Parenteral-nutrition management software.
- Codonics Safe Label System® Administration Tool — CODONICS INC. · Class II
- Codonics Safe Label System®(SLS) 500i Point of Care Station — CODONICS INC. · Class II
- Codonics Safe Label System®(SLS) 550i Point of Care Station — CODONICS INC. · Class II
- Codonics SLS500i Operating Software — CODONICS INC. · Class II
- Codonics Safe Label System®(SLS) 500i Point of Care Station — CODONICS INC. · Class II
- Codonics SLS500i Operating Software — CODONICS INC. · Class II
- Codonics Safe Label System® Administration Tool — CODONICS INC. · Class II
- Codonics SLS500i Operating Software — CODONICS INC. · Class II
Cleared under the same submission
K101439 also covers:
- Codonics SLS500i Operating Software — CODONICS INC.
- Codonics SLS500i Operating Software — CODONICS INC.
- Codonics SLS500i Operating Software — CODONICS INC.
- Codonics SLS500i Operating Software — CODONICS INC.
- Codonics Safe Label System® Administration Tool — CODONICS INC.
- Codonics Safe Label System® Administration Tool — CODONICS INC.
- Codonics Safe Label System®(SLS) 500i Point of Care Station — CODONICS INC.
- Codonics Safe Label System®(SLS) 500i Point of Care Station — CODONICS INC.
- Codonics Safe Label System®(SLS) 550i Point of Care Station — CODONICS INC.
- Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C — CODONICS INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Codonics Inc.
Sources (2)
- FDA UDI d75c3f4e-d28a-49c6-ab4e-3693ff089c2a 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026