FDA UDI
In Commercial Distribution
🇺🇸 United States
VITROS
DI: 10758750033201
·
Model: 6900440
·
ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VITROS
- Primary DI
- 10758750033201
- Version / Model
- 6900440
- Catalog Number
- 6900440
- Company Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Labeler DUNS
- 623873044
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 4
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- de325db5-5665-42aa-ac6a-b8752f3854d7
Device Description
VITROS 4600 Chemistry System - Refurbished
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 10758750033201 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -23.3 – 65.5 Degrees Celsius