FDA UDI
In Commercial Distribution
🇺🇸 United States
Reagent Kit
DI: 07332699000300
·
Model: Reagent
·
M DIALYSIS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reagent Kit
- Primary DI
- 07332699000300
- Version / Model
- Reagent
- Catalog Number
- P000011
- 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
- c505ce0f-7982-4b09-be60-cd3220b05d89
Device Description
Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45467 | Microdialysis system | An assembly of devices intended to be 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. The assembly typically includes a dedicated catheter that is inserted/implanted into tissue (e.g., brain, liver, muscle), a pump that circulates perfusion fluid and interstitial fluid dialysate to and from the site of monitoring, a small vial(s) used to collect samples of dialysate, and an analyser used to determine and display concentrations of analytes (e.g., glucose, lactate, pyruvate) in dialysate samples. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332699000300 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius