Duns Number:078458370
Device Description: The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended fo The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
Catalog Number
-
Brand Name
AbbVie Snug Vest XXL
Version/Model Number
10633
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
f4e1842b-23dc-4ab4-a555-256a71815ea2
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
38054083008166
Quantity per Package
10
Contains DI Package
08054083008165
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 |