Duns Number:200103823
Device Description: disposable CPR faceshield with one way valve and filter
Catalog Number
3000
Brand Name
Faceshield with filter
Version/Model Number
3000
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
c44542de-286c-4514-a6d2-0a78359e4f85
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 07, 2015
Package DI Number
B00230007
Quantity per Package
50
Contains DI Package
B00230000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag of 50
| 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 |