Duns Number:009251992
Device Description: LP12AABCABAACABBAABAAAAALP12 MONITOR-DEFIB
Catalog Number
99400-003521
Brand Name
LIFEPAK® 12 defibrillator/monitor
Version/Model Number
99400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2015
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
5afe96ba-ad26-44c1-92f2-7b39e557796a
Public Version Date
June 03, 2019
Public Version Number
3
DI Record Publish Date
November 05, 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 |