Duns Number:200103823
Device Description: Rescuer disposable CPR facemask with oxygen inlet, head strap, one way valve in a hard she Rescuer disposable CPR facemask with oxygen inlet, head strap, one way valve in a hard shell case
Catalog Number
2025-HS-CC
Brand Name
Rescuer CPR Facemask with O2, head strap, One way Valve in Hard Shell Case
Version/Model Number
2025-HS-CC
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
K010191,K010191
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
c975e5db-2d46-4da9-af0e-55c72f5b7836
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
B0022025HSCC8
Quantity per Package
100
Contains DI Package
B0022025HSCC0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 100
| 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 |