Product code NTZ
- Device name
- Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
- Source
- FDA openFDA device classification dataset