Puritan Bennett Companion 550 Liquid Oxygen Portable Unit
510(k) K933930
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933930 | Date21 Mar 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BYJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5655
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Puritan Bennett Companion 550 Liquid Oxygen Portable Unit is a portable, thermally insulated container of liquid oxygen intended to supplement gases to be inhaled by a patient. It is part of a liquid oxygen system that includes both stationary and portable units for oxygen storage and delivery.
This portable unit is designed to be filled from a stationary liquid oxygen reservoir and is supplied with tubing and an oxygen mask for patient use. The device is a Class II medical product with FDA 510K clearance (K933930) and is regulated under product code BYJ for anesthesiology applications.
Other devices from Puritan Bennett Corp.
Questions
AI-generated answers, 26 Sep 2026
What is the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit used for?
The Puritan Bennett Companion 550 is a portable, thermally insulated container of liquid oxygen designed to supplement gases to be inhaled by patients. It is part of a liquid oxygen system that includes both stationary and portable units for oxygen storage and delivery.
How is the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit supplied?
The portable unit is designed to be filled from a stationary liquid oxygen reservoir and is supplied with tubing and an oxygen mask for patient use, making it convenient for oxygen therapy outside of a clinical setting.
What is the regulatory status of the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit?
The device is a Class II medical product with FDA 510K clearance (K933930) and is regulated under product code BYJ for anesthesiology applications. It received FDA clearance on March 21, 1994.
Can the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit be reused?
The device is designed as a portable unit that can be filled from a stationary reservoir, allowing for multiple uses. However, specific reuse instructions would depend on the manufacturer's guidelines and proper maintenance procedures.