Duns Number:141588017
Device Description: 100 mL EMPTY CONTAINER
Catalog Number
0795123
Brand Name
Hospira
Version/Model Number
795123
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
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
deb486ed-10d8-4a56-a9a9-6383ae9a26fe
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787006838
Quantity per Package
200
Contains DI Package
10887787006831
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. | 7 |