Duns Number:005146311
Device Description: INTRAVIA Container, 150 mL Capacity
Catalog Number
2B8011
Brand Name
INTRAVIA
Version/Model Number
2B8011
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
K964853,K964853,K964853
Product Code
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
cdc19322-5ec7-4e36-9336-0f92568fc8f7
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412003462
Quantity per Package
48
Contains DI Package
20085412003461
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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. | 358 |