FDA UDI
In Commercial Distribution
🇺🇸 United States
Yumizen C1200 AL
DI: 03610230009253
·
Model: CA-20151BM6010C/CA-21391RAMINI
·
HORIBA ABX SAS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Yumizen C1200 AL
- Primary DI
- 03610230009253
- Version / Model
- CA-20151BM6010C/CA-21391RAMINI
- Catalog Number
- 3200675839/3200685493
- Company Name
- HORIBA ABX SAS
- Labeler DUNS
- 273647420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-16
- Public Version
- 3
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 705344e2-edcd-4f32-9dfb-6e09892d2ff9
Device Description
AC 220V Class2 Laser Product + AC100V This device is a combination between the Yumizen C1200 (CA-20151BM6010C) and the autoloader RAmini (CA-21391RAMINI).
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 | 03610230009253 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183375 | 000 |