FDA.reportPublic FDA data

Umbilical cord blood collection set

Definition
A group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.
GUDID devices
35
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00636207302434Pall® CellWash/Infusion Bag SetGlobal Life Sciences Solutions USA LLC791-032016-06-01
00636207302441Pall® Transfer/Freezing Bag SetGlobal Life Sciences Solutions USA LLC791-022016-06-01
00636207302465Pall® Freezing Bag 25 mL with Separable ChamberGlobal Life Sciences Solutions USA LLC791-052016-06-01
00636207314680Briostor™ Transfer/Freezing Bag SetGlobal Life Sciences Solutions USA LLC791-122016-07-20
00749756308151DeRoyalDEROYAL INDUSTRIES, INC.72-80002016-09-12
00749756331951DeRoyalDEROYAL INDUSTRIES, INC.72-8000NS2016-09-12
00749756847568DeRoyalDEROYAL INDUSTRIES, INC.4-105692016-09-12
10195594402969CARDINAL HEALTHCardinal Health 200, LLCSBA31CBNM22021-10-20
10885425366132CARDINAL HEALTHCardinal Health 200, LLCSBA31CBNMA2016-09-27
10888439509298CARDINAL HEALTHCardinal Health 200, LLC33-5327B2019-05-31
B098PS1000Aligned Medical SolutionsAligned Medical SolutionsPS1002018-11-14
H671CRD2010Cordguard®UTAH MEDICAL PRODUCTS, INC.II2017-06-21
30636207307966Anticoagulant Citrate Phosphate Dextrose Solution (CPD)Global Life Sciences Solutions USA LLC791-082022-12-02
50195594402967CARDINAL HEALTHCardinal Health 200, LLCSBA31CBNM22021-10-20
00861880000340Newborn Stem Cell Collection Kit Private kitCRYO-CELL INTERNATIONAL, INC.Private kit2019-10-07
00861880000357Newborn Stem Cell Collection Kit Public KitCRYO-CELL INTERNATIONAL, INC.Public Kit2019-09-18
00861880000364Newborn Stem Cell Collection Kit International KitCRYO-CELL INTERNATIONAL, INC.International Kit2019-09-18
30636207302435Pall® CellWash/Infusion Bag SetPALL CORPORATION791-032016-06-01
30636207302442Pall® Transfer/Freezing Bag SetPALL CORPORATION791-022016-06-01
30636207302466Pall® Freezing Bag 25 mL with Separable ChamberPALL CORPORATION791-052016-06-01
30636207314681Briostor™ Transfer/Freezing Bag SetPALL CORPORATION791-122016-07-20
00812589020351Newborn Stemcell Collection KitVIACORD, LLCViaCord Single Kit2019-04-10
00812589020368Newborn Stemcell Collection KitVIACORD, LLCViaCord Twin Kit2019-04-10
00812589020375Newborn Stemcell Collection KitVIACORD, LLCViaCord Triplet Kit2019-04-10
00812589020382Newborn Stemcell Collection KitVIACORD, LLCViaCord SibCon Single Kit2019-04-10
00812589020399Newborn Stemcell Collection KitVIACORD, LLCViaCord SibCon Twin Kit2019-04-10
00812589020405Newborn Stemcell Collection KitVIACORD, LLCViaCord SibCon Triplet Kit2019-04-10
50749756308156DeRoyalDEROYAL INDUSTRIES, INC.72-80002016-09-12
50749756331956DeRoyalDEROYAL INDUSTRIES, INC.72-8000NS2016-09-12
50749756847563DeRoyalDEROYAL INDUSTRIES, INC.4-105692016-09-12
50885425366130CARDINAL HEALTHCardinal Health 200, LLCSBA31CBNMA2016-09-27
50888439509296CARDINAL HEALTHCardinal Health 200, LLC33-5327B2019-05-31
B039SGI03050SynGenX®-1000Thermogenesis Corp.SGI-03052016-09-24
B098PS1001Aligned Medical SolutionsAligned Medical SolutionsPS1002018-11-14
H671CRD2011Cordguard®UTAH MEDICAL PRODUCTS, INC.II2017-06-21