FETAL BLOOD SAMPLING KIT #1560
Device Facts
| Record ID | K831459 |
|---|---|
| Device Name | FETAL BLOOD SAMPLING KIT #1560 |
| Applicant | Transidyne General Corp. |
| Product Code | HGW · Obstetrics/Gynecology |
| Decision Date | Jun 30, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.
