Duns Number:830767898
Device Description: LATEX-FREE DECANTING SET, 14 Inch For Aseptic Decanting of Fluid from Rubber Stoppered I.V LATEX-FREE DECANTING SET, 14 Inch For Aseptic Decanting of Fluid from Rubber Stoppered I.V. Solution Containers (previously Hospira product)
Catalog Number
0172148
Brand Name
Decanting Set
Version/Model Number
172148
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"
Yes
For Single-Use
Yes
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
616ecd24-d188-46cd-9697-ef5cb69e7dbc
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
May 31, 2018
Package DI Number
20887787006579
Quantity per Package
48
Contains DI Package
10887787006572
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |