Duns Number:108999095
Device Description: CPR Valve Mask Resuscitator,Adult, Orange, w/case 2/pkg
Catalog Number
4053-2
Brand Name
Adsafe
Version/Model Number
4053-2
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
5c4874df-5fdd-4a6f-b861-5574a6f796f0
Public Version Date
May 27, 2019
Public Version Number
1
DI Record Publish Date
May 17, 2019
Package DI Number
00634782596415
Quantity per Package
10
Contains DI Package
00634782095031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |