Duns Number:527333326
Device Description: MANUAL RESUSCITATOR,DURABLE CHILD W/MASK
Catalog Number
5346
Brand Name
LIFESAVER
Version/Model Number
HD-5346
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
-
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
-
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
c406fbab-320e-422d-8d4b-a1e8ada560c4
Public Version Date
October 26, 2020
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
44710810093225
Quantity per Package
12
Contains DI Package
24710810093221
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |