Duns Number:206449154
Device Description: Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective mean Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to perform life saving expired air resuscitation while offering maximum protection from the potential risks of disease transfer for both the patient and the rescuer.The Rescue Breather® CPR Pocket Ventilator comes standard with a disposable Low-Resistance Clear One-Way-Valve with built-in 3M Filtrete® Filter, protected Oxygen inlet, adjustable Head Strap, pair of “Latex Free” Nitrile Gloves, Instructions leaflet and Clam Shell Carrying Case.
Catalog Number
01PV1500W-CS
Brand Name
Rescue Breather
Version/Model Number
01PV1500W
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGB
Product Code Name
Mask, Oxygen, Non-Rebreathing
Public Device Record Key
1b7a720e-5499-46d1-8af5-f7866885b5b5
Public Version Date
May 10, 2019
Public Version Number
1
DI Record Publish Date
May 02, 2019
Package DI Number
17540195056500
Quantity per Package
12
Contains DI Package
07540195056503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |