Duns Number:151860053
Device Description: LIFE®CPR Mask with one-way valve in nylon zip bag.
Catalog Number
-
Brand Name
LIFE®CPR Mask
Version/Model Number
LIFE-100-B
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K010191
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
6042d19d-5f32-441a-97f0-d56cfe1164db
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 29, 2016
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |