Duns Number:118492643
Device Description: FRESH WHOLE BLOOD TRANSFUSION SETDonor Set (PN 80-801-D) 1eaRecipient Set (PN 8 FRESH WHOLE BLOOD TRANSFUSION SETDonor Set (PN 80-801-D) 1eaRecipient Set (PN 80-801-R) 1eaInstructions for Use 1ea
Catalog Number
80-801
Brand Name
Fresh Whole Blood Transfusion Set
Version/Model Number
3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 31, 2023
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
7588ffe3-f0f6-479f-8411-7dfdc5df0e77
Public Version Date
August 10, 2022
Public Version Number
3
DI Record Publish Date
October 01, 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 |