Duns Number:086911794
Device Description: 1 CPR Mask1 Pair Nitrile Gloves2 Benzalkonium Chloride 0.133% Wipes
Catalog Number
8021B
Brand Name
Medi-First CPR Kit
Version/Model Number
8021B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112126,K112126
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
29808f9a-5f19-454e-89fa-f8e3cf26eeec
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
50347682802108
Quantity per Package
30
Contains DI Package
00347682802103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |