Multi-4 CO-Oximeter Control, Level 3
- Primary DI
- 08426950453161
- Brand
- Multi-4 CO-Oximeter Control, Level 3
- Company
- INSTRUMENTATION LABORATORY COMPANY
- Model
- 00003313250
- Catalog number
- 00003313250
- Device description
- Multi-4 CO-Oximeter Control, Level 3
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JJY | Multi-analyte controls, all kinds (assayed) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08426950453161 | Primary | GS1 | 0 | |
| 18426950453168 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08426950453161 | 08426950453161 | 8426950453161 |
| 18426950453168 | 18426950453168 | |
GMDN Terms
| Term | Definition |
|---|
| Multiple blood gas/haemoximetry/electrolyte analyte IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store Multi-4 CO-Oximeter Control at 2-8°C. Each lot of Control has the expiration date stamped on the box and ampule label. |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 557223252
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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