FDA UDI
In Commercial Distribution
🇺🇸 United States
106 Microdialysis Pump
DI: 07332699000034
·
Model: 106
·
M DIALYSIS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 106 Microdialysis Pump
- Primary DI
- 07332699000034
- Version / Model
- 106
- Catalog Number
- P000003
- 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
- 2018-11-29
- Public Version Status
- Update
- Public Device Record Key
- 9e148cb0-8b40-4b9c-9c10-84e86b555b4d
Device Description
Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microdialysis sampling. The pump is prepared with the Battery (07332699000058) and the 106 Syringe (07332699000072) filled with the Perfusion Fluid (07332699000263) and finally connected to the Microdialysis catheter. The 106 Microdialysis Pump is easy to operate. An initial flush is performed automatically. Flushes can be initiated manually if necessary.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 45470 | Microdialysis system pump | An electromechanical device intended to be used to create positive and/or negative pressure to circulate perfusion fluid and interstitial fluid dialysate to and from a monitoring site in a tissue (e.g., brain, liver, muscle), as part of a system used to monitor local 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 |
|---|---|---|---|---|---|---|
| Primary | 07332699000034 | GS1 | ||||
| Direct Marking | 07332699001031 | GS1 |