Duns Number:002687614
Device Description: Defibrilator/AED Tester, External Pacer Analyzer
Catalog Number
2811919
Brand Name
Impulse 7000DP
Version/Model Number
IMPULSE 7000DP
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
-
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
DRL
Product Code Name
Tester, Defibrillator
Public Device Record Key
d4d9a663-6037-4833-9d22-83c9fcb15861
Public Version Date
June 25, 2018
Public Version Number
1
DI Record Publish Date
May 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |