Duns Number:012430880
Device Description: PAD DEFIB CARDIAC SCIENCE
Catalog Number
1127162
Brand Name
Henry Schein
Version/Model Number
1127162
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 06, 2019
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
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
-
Product Code
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
45a1e2ce-0621-439d-a5c2-cbcf4a8b69a7
Public Version Date
March 07, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2016
Package DI Number
10304040016890
Quantity per Package
10
Contains DI Package
00304040016893
Package Discontinue Date
March 06, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |