Duns Number:118492643
Device Description: VALKYRIE LTOWB ADMINISTRATION SETConstricting Band (18" x 1") 1 eaGauze Sponge (4 VALKYRIE LTOWB ADMINISTRATION SETConstricting Band (18" x 1") 1 eaGauze Sponge (4" x 4") 4 eaSafety IV Cath 16G x 1.25" 2 eaPrevahex Transparent Dressing (4" x 4.75") 2 eaIV Set "Y"-Type w-Filter 1 eaBlood Collection Bag 1 eaGloves (Pair) 1 eaChlorhexidine Swab 4 ea5.25" Kelly Clamp 1 eaNeedle Port 2 eaNeedleless Port 2 ea Beaded Cable Tie 1 eaNylon Cord (10") 1 eaASBP 572 1 eaBlood Bag Label 1 eaValkyrie TCCC Card 1 eaInstructions for Use 1 ea
Catalog Number
80-821
Brand Name
Valkyrie LTOWB Administration Set
Version/Model Number
04
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2022
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
POQ
Product Code Name
Blood Transfusion Kit
Public Device Record Key
7e73bc07-9277-4925-acdd-8fc10cd3487c
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
July 19, 2021
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 |