FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Calibration Solution
DI: 05700699440259
·
Model: 944-025
·
Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Calibration Solution
- Primary DI
- 05700699440259
- Version / Model
- 944-025
- Catalog Number
- 944-025
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2023-04-24
- Public Version Status
- Update
- Public Device Record Key
- 6d4f8fd6-cb94-4031-879a-208257bb6ec3
- Distribution End Date
- 2023-02-21
Device Description
S1730 Calibration Solution 2 200 mL, for ABL7XX
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | Clinical Chemistry | 862.1120 | 2 |
| MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM | Clinical Chemistry | 862.1113 | 1 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
| KHP | ACID, LACTIC, ENZYMATIC METHOD | Clinical Chemistry | 862.1450 | 1 |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| CIG | DIAZO COLORIMETRY, BILIRUBIN | Clinical Chemistry | 862.1110 | 2 |
| GKF | INSTRUMENT, HEMATOCRIT, AUTOMATED | Hematology | 864.5600 | 2 |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM | Clinical Chemistry | 862.1145 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35933 | Multiple blood gas analyte IVD, calibrator | A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699440259 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius