FDA.reportPublic FDA data

Blood donor set, single-pack

Definition
An assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.
GUDID devices
32
Last updated
2026-06-13 06:05:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC162026-05-04
03567050035347LCG2b with AS-1, AS-3 and AS-5MACO PHARMAKSV2016-09-22
03567050052740VSE3010XD - Empty Bag 300 mL 6-Way ManMACO PHARMAVSE2016-09-22
03567050069687VSE8004XD - Empty Bag 600 mL 6-Way ManMACO PHARMAVSE2016-09-22
03567050070317VSL7001PD - Therapeutic Phlebotomy Bag w/NeedleMACO PHARMAVSL2016-09-22
03567050070324VSL7000YD - Therapeutic Phlebotomy BagMACO PHARMAVSL2016-09-22
03567051503111VSE4002XD - Empty Bag 600 mLMACO PHARMAVSE2016-09-22
10887691000307Cardioplegia PlusHAEMONETICS CORPORATIONCPS022017-01-19
10887691000673HaemoneticsHAEMONETICS CORPORATIONSQ40SK2017-02-06
10887691000680HaemoneticsHAEMONETICS CORPORATIONSQ40SY2017-02-02
10887691001243LipiGuard SBHAEMONETICS CORPORATIONSB1E2017-01-19
M68980801D090Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC092022-08-24
M68980801D150Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC152025-03-04
M68980801D140Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC142024-12-16
13567050035344LCG2b with AS-1, AS-3 and AS-5MACO PRODUCTIONSKSV2016-09-22
13567050052747VSE3010XD - Empty Bag 300 mL 6-Way ManMACO PRODUCTIONSVSE2016-09-22
13567050069684VSE8004XD - Empty Bag 600 mL 6-Way ManMACO PRODUCTIONSVSE2016-09-22
13567050070314VSL7001PD - Therapeutic Phlebotomy Bag w/NeedleMACO PRODUCTIONSVSL2016-09-22
13567050070321VSL7000YD - Therapeutic Phlebotomy BagMACO PRODUCTIONSVSL2016-09-22
00842209128198NARNORTH AMERICAN RESCUE, LLC83-00352023-08-10
M68980801D110Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC112022-08-09
M68980801D0Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC12017-02-06
M68980801D080Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC82022-02-08
M68980801D070Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC72021-10-04
M68980801D040Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC42020-04-03
M68980801D020Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLC22017-08-04
13567051503118VSE4002XD - Empty Bag 600 mLMACO PRODUCTIONSVSE2016-09-22
30887691000301Cardioplegia PlusHAEMONETICS CORPORATIONCPS022017-01-19
30887691000677HaemoneticsHAEMONETICS CORPORATIONSQ40SK2017-02-06
30887691000684HaemoneticsHAEMONETICS CORPORATIONSQ40SY2017-02-02
30887691001247LipiGuard SBHAEMONETICS CORPORATIONSB1E2017-01-19
00842209103720NARNORTH AMERICAN RESCUE, LLC83-00012018-09-14