FDA UDI
In Commercial Distribution
🇺🇸 United States
Stat Profile
DI: 00385480646048
·
Model: Prime Plus
·
NOVA BIOMEDICAL CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stat Profile
- Primary DI
- 00385480646048
- Version / Model
- Prime Plus
- Catalog Number
- 64604
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-06
- Public Version
- 1
- Public Version Date
- 2022-06-14
- Public Version Status
- New
- Public Device Record Key
- 30221c82-50bd-4db1-ac54-43756c86148b
Device Description
Stat Profile Prime Plus MicroSensor Card™ 100
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
- Yes
- 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 |
|---|---|---|---|---|
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| GGZ | OXYHEMOGLOBIN | Hematology | 864.7500 | 2 |
| CHL | Electrode measurement, blood-gases (pco2, po2) and blood ph | Clinical Chemistry | 862.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56681 | Single-channel clinical chemistry analyser IVD, point-of-care | 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 one or multiple clinical chemistry analytes in a clinical specimen. Analytes measured include multiple clinical chemistry analytes such as glucose, ketone, specific proteins, clinical chemistry substrates, enzymes and/or a lipid profile, using a single technology such as electrometry, spectrophotometry, fluorimetry, radiometry or chemiluminescence. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385480646045 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00385480646048 | GS1 |
Customer Contacts
- Phone
- +1(800)545-6682
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius