Catalog Number
-
Brand Name
AtriAmp
Version/Model Number
10001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200674,K200674,K200674
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
417c3b9c-a845-40f2-b347-825b9f8a1cb2
Public Version Date
January 11, 2021
Public Version Number
1
DI Record Publish Date
January 01, 2021
Package DI Number
10860004773709
Quantity per Package
5
Contains DI Package
00860004773702
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton