Duns Number:632662933
Device Description: LUCAS BATTERY DARK GRAY
Catalog Number
11576-000080
Brand Name
LUCAS CHEST COMPRESSION SYSTEM
Version/Model Number
11576
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
DRM
Product Code Name
Compressor, cardiac, external
Public Device Record Key
4ef5f64b-2410-4ccd-ae64-d8acecacd84e
Public Version Date
October 31, 2018
Public Version Number
3
DI Record Publish Date
November 14, 2016
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. | 6 |