FDA UDI
In Commercial Distribution
🇺🇸 United States
Stat Profile
DI: 00385480614535
·
Model: Prime ES Plus
·
NOVA BIOMEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stat Profile
- Primary DI
- 00385480614535
- Version / Model
- Prime ES Plus
- Catalog Number
- 61453
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 1
- Public Version Date
- 2020-02-11
- Public Version Status
- New
- Public Device Record Key
- 4f146be3-fa42-41f9-90fb-9aa755826c03
Device Description
Prime Sensor Card ES Plus
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| CHL | Electrode measurement, blood-gases (pco2, po2) and blood ph | Clinical Chemistry | 862.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56680 | Multichannel clinical chemistry analyser IVD, point-of-care, line-powered | A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, metabolites, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, enzymatic chemistry, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385480614532 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00385480614535 | GS1 |
Customer Contacts
- Phone
- +1(800)545-6682
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius