FDA UDI
In Commercial Distribution
🇺🇸 United States
Codonics SLS500i Operating Software
DI: 00814905020007
·
Model: 2.1.1
·
CODONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Codonics SLS500i Operating Software
- Primary DI
- 00814905020007
- Version / Model
- 2.1.1
- Company Name
- CODONICS INC.
- Labeler DUNS
- 101533727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4824e6aa-9f80-40d9-a0b8-cf6f1baa5e74
Device Description
V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | Anesthesiology | 868.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18169 | Parenteral-nutrition management software | A software program intended to facilitate the management of the ordering, calculation, and preparation of customizable parenteral nutrition dosages for individual patients, according to physician prescriptions. It is used in conjunction with filling and compounding machines in hospital pharmacies and compounding centres to enable the automated and systematic production of parenteral nutrition dosages. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814905020007 | GS1 |
Customer Contacts
- Phone
- 4402431334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101439 | 000 |