FDA UDI
In Commercial Distribution
🇺🇸 United States
Chemistry Analyzer
DI: 06944904084459
·
Model: CLC720i
·
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Chemistry Analyzer
- Primary DI
- 06944904084459
- Version / Model
- CLC720i
- Company Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Labeler DUNS
- 654671304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- a4f82dc5-392f-4902-a7b7-c555bef68708
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | Clinical Chemistry | 862.1770 | 2 |
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | 862.1600 | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | Clinical Chemistry | 862.1170 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 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 |
|---|---|---|---|---|---|---|
| Primary | 06944904084459 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140690 | 000 |