Duns Number:206449154
Device Description: The Rescue Breather consists of a one-way valve that has a large block is placed in a pati The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider.
Catalog Number
01RB1000
Brand Name
Rescue Breather
Version/Model Number
01RB1000U
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"
Yes
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
K940927,K940927
Product Code
LYM
Product Code Name
Device, Cpr Assist
Public Device Record Key
9d3dc24c-ddaa-474b-8f01-8db7f1f095cb
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
17540195055015
Quantity per Package
50
Contains DI Package
07540195055018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Packaging box
| 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 |