Duns Number:079320559
Catalog Number
10A1072
Brand Name
ZOLL Charger
Version/Model Number
Charger
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K172510,K190939
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
398e327b-141e-4914-ab11-b224b2610bfa
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
May 17, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |
3 | A medical device with high risk that requires premarket approval | 15 |