Duns Number:025460908
Device Description: CVC TRAY
Catalog Number
DYNDC1903A
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
DYNDC1903A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 15, 2022
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
OFF
Product Code Name
Central venous catheter tray
Public Device Record Key
57b0854e-dd3a-4efc-9dab-68f6b8733488
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
40884389957937
Quantity per Package
40
Contains DI Package
10884389957936
Package Discontinue Date
March 15, 2022
Package Status
Not 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 | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |