BZB · Catheter, Nasal, Oxygen
Anesthesiology · 21 CFR 868.5350 · Class 1
Overview
| Product Code | BZB |
|---|---|
| Device Name | Catheter, Nasal, Oxygen |
| Regulation | 21 CFR 868.5350 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896731 | OXYGEN CATHETERS | Unoplast A/S | Mar 30, 1990 | SESE |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | Zimmar Consulting , Ltd. | Nov 19, 1984 | SESE |
| K833351 | DEMAND OXYGEN CONTROLLER | Healthdyne, Inc. | Mar 19, 1984 | SESE |
| K830984 | OXYGEN CATHETERS | Medovations, Inc. | May 18, 1983 | SESE |
| K820370 | NASAL OXYGEN CATHETER | American Pharmaseal Div. Ahsc | Apr 16, 1982 | SESE |
| K800506 | OXYGEN CATHETER | Medi-Craft , Ltd. | Mar 25, 1980 | SESE |
| K791273 | CONPHAR OXYGEN CATHETER-STERILE | Conphar, Inc. | Jul 24, 1979 | SESE |
| K790057 | CATHETER, OXYGEN | Medline Industries, Inc. | Feb 5, 1979 | SESE |
Top Applicants
- Zimmar Consulting , Ltd. — 1 clearance
- Unoplast A/S — 1 clearance
- Medovations, Inc. — 1 clearance
- Medline Industries, Inc. — 1 clearance
- Medi-Craft , Ltd. — 1 clearance
