FDA UDI
In Commercial Distribution
🇺🇸 United States
HIGH METABOLITE QC, LEVEL 1
DI: 05700699440990
·
Model: 944-099
·
Radiometer Medical ApS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- HIGH METABOLITE QC, LEVEL 1
- Primary DI
- 05700699440990
- Version / Model
- 944-099
- Catalog Number
- 944-099
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- 3758cda3-c0ee-4e76-9b36-2ca643caf3f9
Device Description
S7570 QUALICHECK, level 1 High Metabolite - RED box of 30 ampoules. For ABL520/555, ABL7XX, EML105, NPT7
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JJS | Controls for blood-gases, (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52860 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 55700699440995 | GS1 | ||||
| Primary | 05700699440990 | GS1 |
Customer Contacts
- Phone
- +4538273827
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius