BZBClass I
Catheter, Nasal, Oxygen
21 CFR 868.5350 / Anesthesiology
BZB is the FDA product code for Catheter, Nasal, Oxygen, a class I device type, regulated under 21 CFR 868.5350. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- BZB
- Device name
- Catheter, Nasal, Oxygen
- Regulation
- 21 CFR 868.5350
- Device class
- Class I
- Review panel
- Anesthesiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 1
Clearances, product code BZB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1990 | 1 |
Applicants with the most clearances
Product code BZB| Applicant | Clearances |
|---|---|
| American Pharmaseal Div. Ahsc | 1 |
| Conphar, Inc. | 1 |
| Healthdyne, Inc. | 1 |
| Medi-Craft, Ltd. | 1 |
| MEDLINE INDUSTRIES, LP - Northfield | 1 |
| Medovations, Inc. | 1 |
| Unoplast A/S | 1 |
| Zimmar Consulting, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
