Duns Number:968998641
Device Description: REV KIT, VIBE PEDS P1, LGN,mg,US
Catalog Number
11851500
Brand Name
Animas Vibe
Version/Model Number
11851500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
OYC
Product Code Name
Pump, infusion, insulin, to be used with invasive glucose sensor
Public Device Record Key
094fde9b-3612-4fd3-9450-44f70f87f9a9
Public Version Date
August 04, 2021
Public Version Number
4
DI Record Publish Date
March 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. | 12 |
3 | A medical device with high risk that requires premarket approval | 45 |