Duns Number:009251992
Device Description: LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
Catalog Number
97402-000003
Brand Name
LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors
Version/Model Number
97402
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
33c3a633-c885-4e75-98d5-bef8e249e8c5
Public Version Date
May 01, 2019
Public Version Number
3
DI Record Publish Date
October 20, 2014
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 588 |