Duns Number:029062325
Device Description: Neonatal/Pediatric Syringe Set 150µ filter and syringe adapter
Catalog Number
03-960-32
Brand Name
N/A
Version/Model Number
03-960-32
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
K000685,K000685
Product Code
BRZ
Product Code Name
Set, Blood Transfusion
Public Device Record Key
3673f41f-b9a2-4c6b-8d3e-2d266443215d
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00817827022579
Quantity per Package
48
Contains DI Package
00817827022074
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 |