Duns Number:141608724
Device Description: ACCU-CHEK 360 INSULIN PUMP CONFIG SW US
Catalog Number
06604765001
Brand Name
ACCU-CHEK 360
Version/Model Number
06604765001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 17, 2021
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
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
d3e395d5-9927-48d1-942d-b32d3d59f025
Public Version Date
September 20, 2021
Public Version Number
3
DI Record Publish Date
August 26, 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 |
|---|---|---|
| 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. | 63 |
| 3 | A medical device with high risk that requires premarket approval | 3 |