Duns Number:029062325
Device Description: Neonatal/Pediatric Syringe Set 40µ Filter with Syringe Adapter
Catalog Number
N40-960-33
Brand Name
N/A
Version/Model Number
N40-960-33
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K990310,K990310
Product Code
CAK
Product Code Name
Microfilter, Blood Transfusion
Public Device Record Key
68af5822-3a30-4fd4-a8e0-49f076238ba7
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00817827024535
Quantity per Package
48
Contains DI Package
00817827024030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| U | Unclassified | 7 |