Besmed Single Use Adult, Child, Infant Manual Resuscitator With Mask & Reservoir
by Oemedic International, Inc.
510(k) K021442
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021442 | Date30 Jul 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Oemedic International Inc. Besmed Single Use Adult, Child, Infant Manual Resuscitator with Mask & Reservoir
- 510(k) Number
- FDA Product Code
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Besmed Single Use Manual Resuscitator is a single-use, manual ventilation device classified as an emergency manual resuscitator. It delivers positive pressure ventilation to patients with respiratory insufficiency or failure, featuring a self-inflating bag, patient valve, mask, and oxygen reservoir designed for use across three weight-based categories: infant, child, and adult. Constructed from silicone, the device is intended for clinical use by trained healthcare professionals in settings such as hospitals or emergency care environments.
Supplied as a single-use device, the Besmed Manual Resuscitator is intended for one-time use and must be discarded after use. It is not reusable and requires no sterilization. The device is non-magnetic and safe for use in MRI environments. Sizes are categorized by patient weight (infant, child, adult) to ensure appropriate tidal volume delivery. Authorized under FDA 510(k) clearance (K021442), it adheres to regulatory standards for emergency manual resuscitators.
Other devices from Oemedic International, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Besmed Single-Use Manual Resuscitator used for?
The Besmed Single-Use Manual Resuscitator is designed to provide positive pressure ventilation for patients experiencing respiratory insufficiency or failure. It is intended for use by trained healthcare professionals in emergency settings, such as hospitals or clinics, to assist patients who require temporary respiratory support.
How is the Besmed Manual Resuscitator supplied and intended for use?
The Besmed Manual Resuscitator is supplied as a single-use device, meaning it is intended for one-time clinical use only. After use, the entire device must be discarded to ensure patient safety and prevent cross-contamination. It does not require sterilization or reuse.
Is the Besmed Manual Resuscitator safe for use in MRI environments?
Yes, the Besmed Manual Resuscitator is explicitly designed to be non-magnetic, making it safe for use in MRI environments. This ensures compatibility with magnetic resonance imaging procedures without interference.
What sizes or models are available for the Besmed Manual Resuscitator?
The Besmed Manual Resuscitator is categorized by patient weight to ensure appropriate tidal volume delivery: infant, child, and adult. Each size is tailored to the specific respiratory needs of the respective age group, providing optimal ventilation support.
How should the Besmed Manual Resuscitator be stored?
Since the Besmed Manual Resuscitator is a single-use device, it should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Follow manufacturer guidelines for packaging integrity to maintain sterility until first use.