Duns Number:009251992
Device Description: ASSY-LP CR PLUS,SEMI,CHECK FOR PULSE
Catalog Number
97403-000001
Brand Name
LIFEPAK® CR Plus and LIFEPAK Express defibrillators
Version/Model Number
97403
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 07, 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
83d346d2-93f4-49eb-8f85-d2cd77867066
Public Version Date
May 09, 2019
Public Version Number
3
DI Record Publish Date
November 14, 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 |