FDA UDI
In Commercial Distribution
🇺🇸 United States
GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml
DI: 04260341780603
·
Model: 30.9.0290
·
G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml
- Primary DI
- 04260341780603
- Version / Model
- 30.9.0290
- Catalog Number
- 30.9.0290
- Company Name
- G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
- Labeler DUNS
- 319441788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-05-07
- Public Version
- 1
- Public Version Date
- 2021-05-17
- Public Version Status
- New
- Public Device Record Key
- 469b4059-ab40-481e-881b-3024a2b9d732
Device Description
OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIS | Calibrator, Primary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52885 | Osmolality IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04260341780764 | GS1 | ||||
| Primary | 04260341780603 | GS1 |
Customer Contacts
- Phone
- +493078095880
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius