FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EPOC BGEM CREA TEST CARD, VET, HESKA
DI: 00809708086145
·
Model: CT-1007-US-00
·
Epocal Inc
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPOC BGEM CREA TEST CARD, VET, HESKA
- Primary DI
- 00809708086145
- Version / Model
- CT-1007-US-00
- Company Name
- Epocal Inc
- Labeler DUNS
- 201179681
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 3
- Public Version Date
- 2020-12-02
- Public Version Status
- Update
- Public Device Record Key
- d5df4fbc-d3e2-4b57-a54b-d4f8780308c2
- Distribution End Date
- 2020-12-02
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|---|---|
| Primary | 00809708086145 | GS1 |