FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO
DI: 10758750012817
·
Model: 6904577
·
ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHO
- Primary DI
- 10758750012817
- Version / Model
- 6904577
- Catalog Number
- 6904577
- Company Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Labeler DUNS
- 068715424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 7
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- e9949e55-f483-4536-aeaa-602ba9e98572
Device Description
ORTHO VISION™ Analyzer (MTS)
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 |
|---|---|---|---|---|
| KSZ | SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57846 | Immunohaematology/blood bank analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening/identification/titration, direct antiglobulin tests and/or crossmatching of clinical specimens (from donor and patient). It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750012817 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 45 Degrees Celsius