Duns Number:055363428
Device Description: STAT PADZ, ZOLL DEFIB ADULT, 1-SET, INT
Catalog Number
-
Brand Name
STAT-PADZ
Version/Model Number
8900-5001
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRK
Product Code Name
Dc-defibrillator, high energy, (including paddles)
Public Device Record Key
22f2aa30-505c-4ed3-abe7-7da4fa06e9b7
Public Version Date
February 08, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2014
Package DI Number
10847946016491
Quantity per Package
12
Contains DI Package
00847946016494
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |