Duns Number:118492643
Device Description: ADVANCED LTOWB COLLECTION SETConstricting Band (18" x 1") 1 eaGauze Sponge ADVANCED LTOWB COLLECTION SETConstricting Band (18" x 1") 1 eaGauze Sponge 2 eaSafety IV Cath 16G x 1.25" 2 eaPrevahex Transparent Dressing (4" x 4.75") 2 eaBlood Collection Bag 1 eaGloves (Pair) 1 prChlorhexidine Swab 2 eaKelly Clamp 1 eaNeedle Port 2 eaBeaded 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
80-820
Brand Name
Valkyrie LTOWB Collection Set
Version/Model Number
06
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
POQ
Product Code Name
Blood Transfusion Kit
Public Device Record Key
ac68e6d9-c199-4550-bbcb-f6ba923808f7
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
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 |