Duns Number:154199392
Device Description: 12V 4.3AH NIMH BATTERY PACK
Catalog Number
AS36320
Brand Name
ALPHA SOURCE BATTERY
Version/Model Number
AS36320
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
K922909
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
6dc35d71-6fa1-4160-8ea4-62e0dac5523e
Public Version Date
June 28, 2019
Public Version Number
1
DI Record Publish Date
June 20, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 37 |
3 | A medical device with high risk that requires premarket approval | 26 |