Duns Number:688006266
Device Description: Description: The battery is an accessory for insulin pump use. it is the main power of DAN Description: The battery is an accessory for insulin pump use. it is the main power of DANA insulin pump.
Catalog Number
-
Brand Name
3.6V Battery
Version/Model Number
Bobbin
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063126,K063126
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
7079739f-0f6c-44ed-b857-f9d7bc484ec1
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
08809220581021
Quantity per Package
8
Contains DI Package
08809220581014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |