FDA UDI
In Commercial Distribution
🇺🇸 United States
ISCUSflex
DI: 07332699000607
·
Model: Clinical
·
M DIALYSIS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ISCUSflex
- Primary DI
- 07332699000607
- Version / Model
- Clinical
- Catalog Number
- 8003295
- Company Name
- M DIALYSIS INC.
- Labeler DUNS
- 824632087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- f026ada0-837e-4c85-a167-a8d8f7f1bbad
Device Description
Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45468 | Microdialysis system analyser | An instrument that may use one of several analytical techniques (e.g., spectrophotometry) to determine and display the concentration of analytes (e.g., glucose, lactate, pyruvate) in an interstitial fluid dialysate sample, as part of an assembly of devices used to monitor local body-tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07332699000744 | GS1 | ||||
| Primary | 07332699000607 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 28 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius