(129 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functional performance of a CPR mask, with no mention of AI or ML capabilities.
No.
A CPR mask is a barrier device used during cardiopulmonary resuscitation to protect the rescuer and facilitate ventilation, but it does not treat or cure a disease or condition, which is the definition of a therapeutic device.
No
The device is described as a CPR mask used for ventilation and as a barrier during cardiopulmonary resuscitation, indicating a therapeutic or protective function, not a diagnostic one.
No
The device description clearly states it is made of physical materials (medical grade PVC, K-resin) and includes physical components (mask, valve, strap). It is a hardware device used for ventilation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mouth-to-mask ventilation during CPR and as a barrier. This is a physical intervention performed on a patient.
- Device Description: The description details the physical components of the mask and valve.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Using reagents or other in vitro methods.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This CPR mask is a medical device used on the body to facilitate breathing during an emergency.
N/A
Intended Use / Indications for Use
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a nonbreathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.
Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
Specifications:
Dimensions: (122mm x 100mm x 90mm) mask connector 22mm ID oxygen port 6mm OD Inspiratory resistance:
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
Nov. 28. 2011
DEC – 1 2011
Submitter: Genuine First Aid LLC 600 Cleveland Street Suite 400 Clearwater FL 33755, USA Office: (727) 449 2150 Fax: Contact: Desiree Jacques
Contact/Consultant: Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd East Stroudsburg, PA 18301 USA (570) 620-0198 (570) 620-0199
Trade Name: Genuine First Aid CPR Mask
Common Name: Emergency CPR Mask
Classification Name: Valve, Non-Rebreathing Product Code: CBP Classification: Class II Panel: Anesthesiology Regulatory Classification: 21CFR 868.5870
Predicate Device: Medisource CPR Mask without Oxygen Port - K081516 LIV Medica CPR Face Mask - K052458
Device Description:
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.
Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
Specifications:
Dimensions: (122mm x 100mm x 90mm) mask connector 22mm ID oxygen port 6mm OD Inspiratory resistance: