Duns Number:005083209
Device Description: ExactaMix EMPTY EVA dual Chamber container with screw connectors, 3L
Catalog Number
H938905
Brand Name
EXACTAMIX
Version/Model Number
H938905
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
K960581,K960581
Product Code
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
513dc067-90be-4366-b83d-bd26cc05b7a6
Public Version Date
October 17, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
50085412477478
Quantity per Package
42
Contains DI Package
00085412477473
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |