Duns Number:006261481
Device Description: IV DECANTER 40040 FLEX TUBE-CLAMP 20P 17
Catalog Number
-
Brand Name
DLP®
Version/Model Number
40040
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K812852,K812852
Product Code
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
7c5747f9-50a2-4f49-8abb-6de2da63bede
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
June 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |