Duns Number:799455241
Device Description: Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform.
Catalog Number
8700-0752-21
Brand Name
AutoPulse Li-ion Battery™
Version/Model Number
100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112998
Product Code
DRM
Product Code Name
Compressor, Cardiac, External
Public Device Record Key
9f530d37-4f4b-40d4-a3d7-cf14795a58e9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 24, 2015
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. | 331 |
| 3 | A medical device with high risk that requires premarket approval | 1 |