Duns Number:118492643
Device Description: FRESH WHOLE BLOOD RECIPIENT SETConstricting Band (18"x1") 1 eaGauze Sponge FRESH WHOLE BLOOD RECIPIENT SETConstricting Band (18"x1") 1 eaGauze Sponge 2 eaSafety IV Catheter 16gx1.25" 1 eaSafety IV Catheter 18gx1.25" 1 eaIV Set "Y" - Type with Filter 1 eaSurgical Tape 1 eaClear IV Dressing 1 eaABO/Rh Screen (EldonCard) 1 eaGloves 1 prAlcohol Pads 2 eaChlorhexidine Swab 1 eaPermanent Marker 1 eaSF 518 1 eaInstructions for Use 1 ea
Catalog Number
80-801-R
Brand Name
Fresh Whole Blood Recipient Set
Version/Model Number
07
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
35cc04c2-1be5-48dc-9eb9-cafeff08cda3
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 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 |