Duns Number:043046283
Device Description: EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors
Catalog Number
66615
Brand Name
SECURE®
Version/Model Number
66615
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
dcee3dea-0a13-4685-9d6c-7bd5770ff4ca
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50812496011461
Quantity per Package
42
Contains DI Package
00812496011466
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |