FDA UDI
In Commercial Distribution
🇺🇸 United States
Microvials in rack, Sterile 12x4
DI: 07332699000645
·
Model: Sterile
·
M DIALYSIS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Microvials in rack, Sterile 12x4
- Primary DI
- 07332699000645
- Version / Model
- Sterile
- Catalog Number
- P000154
- Company Name
- M DIALYSIS INC.
- Labeler DUNS
- 824632087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9c9ce31b-631e-4387-ba17-0b44eeda4261
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07332699000645 | GS1 | ||||
| Unit of Use | 07332699000980 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature