Duns Number:008124539
Device Description: Resp-O2 CPR Rescue Mask Kit, 1 Pair Vinyl Gloves, 1 PC Rescue Mask
Catalog Number
-
Brand Name
Resp-O2 CPR Rescue Mask Kit
Version/Model Number
36022
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
4068cf76-d324-463a-9e96-84e95f8aefe0
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 14, 2022
Package DI Number
00840117309913
Quantity per Package
25
Contains DI Package
00840117309906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |