Duns Number:118492643
Device Description: LOW TITER TYPE O FWB TRANSFUSION SETConstricting Band (18"x1") 1 eaSafety IV Catheter 16g LOW TITER TYPE O FWB TRANSFUSION SETConstricting Band (18"x1") 1 eaSafety IV Catheter 16gx1.25" 2 eaIV Set "Y" - Type with Filter 1 eaTransparent Film Dressing 2 eaChlorhexidine Swap 4 eaBlood Collection Bag 1 eaBeaded Cable Tie 1eaNeedle-Free Valve with Luer Lock 2 eaDD Form 572 1 eaSF518 1 ea
Catalog Number
80-875
Brand Name
Low Titer Type O FWB Transfusion Set
Version/Model Number
02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
BRZ
Product Code Name
Set, Blood Transfusion
Public Device Record Key
e974dbea-79e2-4ae5-8fb7-18e837de27f9
Public Version Date
April 12, 2022
Public Version Number
3
DI Record Publish Date
September 18, 2018
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |