Duns Number:078458370
Device Description: The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
Catalog Number
-
Brand Name
Abbvie Fitted Vest XL
Version/Model Number
0AV551
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQG
Product Code Name
Adaptor, Holder, Syringe
Public Device Record Key
e255386c-abb2-4bdb-bf7e-16adee365593
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
38054083022476
Quantity per Package
15
Contains DI Package
08054083022475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |