FDA UDI
In Commercial Distribution
🇺🇸 United States
RAPIDLab® 348/348EX HCT Slope
DI: 00630414055930
·
Model: 10309776
·
Siemens Healthcare Diagnostics Inc.
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- RAPIDLab® 348/348EX HCT Slope
- Primary DI
- 00630414055930
- Version / Model
- 10309776
- Catalog Number
- 105670
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- a95e7b0e-7358-405a-a365-7c148154162b
Device Description
RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
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
- 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 |
|---|---|---|---|---|
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM | Clinical Chemistry | 862.1145 | 2 |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | Clinical Chemistry | 862.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52859 | Multiple blood gas/haemoximetry/electrolyte analyte 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 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 |
|---|---|---|---|---|---|---|
| Primary | 00630414055930 | GS1 | ||||
| Unit of Use | 00630414010045 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962021 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius