Duns Number:200103823
Device Description: Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute episodes of respiratory distress.
Catalog Number
8705
Brand Name
Rescuer Emergency CPAP System
Version/Model Number
8705
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K122610
Product Code
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
2eecb79d-c459-4134-8a4c-1a0ee0806b56
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 05, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |