FDA UDI
In Commercial Distribution
🇺🇸 United States
Luer Capillary
DI: 00630414202433
·
Model: 10323407
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Luer Capillary
- Primary DI
- 00630414202433
- Version / Model
- 10323407
- Catalog Number
- 106050
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-07-09
- Public Version
- 2
- Public Version Date
- 2022-01-19
- Public Version Status
- Update
- Public Device Record Key
- d0cde78d-ba78-4616-8362-7e1081febd89
Device Description
Luer Capillary (pack of 2) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIO | TUBE, COLLECTION, CAPILLARY BLOOD | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52861 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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 | 00630414299181 | GS1 | ||||
| Primary | 00630414202433 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]