FDA UDI
In Commercial Distribution
🇺🇸 United States
A20 Advanced Automated Osmometer
DI: 00816068020641
·
Model: A2O
·
ADVANCED INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A20 Advanced Automated Osmometer
- Primary DI
- 00816068020641
- Version / Model
- A2O
- Catalog Number
- A2O
- Company Name
- ADVANCED INSTRUMENTS, INC.
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 8c621409-6406-4add-96a0-9c959614ad82
Device Description
Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJM | Osmometer For Clinical Use | Clinical Chemistry | 862.2730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57853 | Osmometric analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816068020641 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]