Duns Number:009251992
Device Description: KIT, SHIPPING, SINGLE ELECTRODE, LPCR2, LL,MULTI
Catalog Number
11101-000021
Brand Name
NA
Version/Model Number
11101
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"
Yes
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
P170018
Product Code
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
eb122eb6-fdf1-44d7-9033-3e0234918764
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
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 |