FDA UDI
In Commercial Distribution
🇺🇸 United States
STAT PROFILE
DI: 00385480239622
·
Model: PHOX
·
NOVA BIOMEDICAL CORPORATION
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STAT PROFILE
- Primary DI
- 00385480239622
- Version / Model
- PHOX
- Catalog Number
- 23962
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3f47b90d-abe0-4cce-bdbb-aed65c385933
Device Description
Remanufactured Stat Profile pHOx Analyzer
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | Clinical Chemistry | 862.1150 | 2 |
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | Hematology | 864.5620 | 2 |
| JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide | Clinical Toxicology | 862.3220 | 1 |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | Hematology | 864.8625 | 2 |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | Clinical Chemistry | 862.1120 | 2 |
| JPI | DEVICE, HEMATOCRIT MEASURING | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56672 | Blood gas/haemoximetry analyser IVD, point-of-care | A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385480239629 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00385480239622 | GS1 |
Customer Contacts
- Phone
- +1(800)545-6682
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014295 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- 0 ft to 15000 ft
- Type
- Special Storage Condition, Specify
- Special Conditions
- Without Condensation
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity