Duns Number:093370369
Catalog Number
-
Brand Name
Empty IV Bag 500mL
Version/Model Number
099731320000
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
b1971187-0918-4d70-a3f5-84dc1cd1c335
Public Version Date
February 01, 2019
Public Version Number
1
DI Record Publish Date
January 01, 2019
Package DI Number
10853620005194
Quantity per Package
50
Contains DI Package
00853620005197
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |