Duns Number:078458370
Device Description: The Hip Pack is designed to carry a CADD-Legacy® 1400 pump. This Hip Pack is intended for The Hip Pack is designed to carry a CADD-Legacy® 1400 pump. This Hip Pack is intended for single-patient use only. The Hip Pack is intended to be worn around the waist.
Catalog Number
-
Brand Name
AbbVie Hip Pack
Version/Model Number
10637
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
d1246213-f28f-497c-8233-2fe5004e5d2d
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
38054083007954
Quantity per Package
10
Contains DI Package
08054083007953
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 |