Duns Number:029062325
Device Description: Neonatal/Pediatric Syringe Set 150µ filter and 35cc syringe; not manufactured with DEHP
Catalog Number
03-960-35F
Brand Name
N/A
Version/Model Number
03-960-35F
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
201da214-0e79-4185-9443-e274143e113c
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00817827022623
Quantity per Package
24
Contains DI Package
00817827022128
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 |