FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe Waste System Spectrophotometer for Pharmaceutical Analysis
DI: 00814905021479
·
Model: SWS
·
CODONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Safe Waste System Spectrophotometer for Pharmaceutical Analysis
- Primary DI
- 00814905021479
- Version / Model
- SWS
- Company Name
- CODONICS INC.
- Labeler DUNS
- 101533727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- 0ae33be6-e800-4251-a87c-b4ecc09f9680
Device Description
Safe Waste System Spectrophotometer for Clinical Use-Pharmaceutical Analysis
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
- Yes
- 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 |
|---|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56676 | Multiple clinical chemistry analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00814905021486 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00814905021479 | GS1 |
Customer Contacts
- Phone
- 440-243-1198
- [email protected]