Duns Number:092519016
Device Description: MR AED II
Catalog Number
72741
Brand Name
Mid Range AED II
Version/Model Number
72741
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"
-
For Single-Use
-
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
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
f54d5112-8135-48d0-bae5-72e9cb48fce4
Public Version Date
April 23, 2020
Public Version Number
1
DI Record Publish Date
April 15, 2020
Package DI Number
B800727415
Quantity per Package
5
Contains DI Package
B800727410
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 113 |