Duns Number:200103823
Device Description: Rescuer disposable CPR mask with oxygen inlet, head strap, one way valve, hard shell case Rescuer disposable CPR mask with oxygen inlet, head strap, one way valve, hard shell case and 2 nitrile gloves
Catalog Number
2025-HS-CCX
Brand Name
Rescuer 2025-HS-CC with Nitrile gloves
Version/Model Number
2025-HS-CCX
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
5cd7f91f-f7f5-4497-9caa-dbd688863e3d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
B0022025HSCCX8
Quantity per Package
100
Contains DI Package
B0022025HSCCX0
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 |