FDA.reportPublic FDA data

Apheresis system tubing set

Definition
A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.
GUDID devices
126
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System AssemblyFresenius Kabi AG4R2353G2020-10-20
00810020440270AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS SpikeFresenius Kabi AG4R23582023-05-22
00810020440706Amicus Single Needle Advanced Kit with Platelet Additive Solution ConnectorFresenius Kabi AG4R23512022-04-11
00810020440713Amicus Double Needle Advanced Kit with Platelet Additive Solution ConnectorFresenius Kabi AG4R23522022-04-11
00810020440768AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS SpikeFresenius Kabi AG4R23592023-05-22
00810020441116PLASMACELL Xi Disposable Set with SPIKESMARTFresenius Kabi AG6R2600P2023-02-24
00810020441635Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AG4R23602024-01-24
00810020441642Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AG4R23612024-01-24
00810020442229Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGX7R2326SB2026-02-03
00811137010127ALYX™ 2RBC-LR KitFENWAL, INC.4R57202016-09-08
00811137012411Apheresis Needle with MASTERGUARD ProtectorFENWAL, INC.4R24412016-09-02
00842289100800Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7006MGLB2016-09-16
00842289100817Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7007MGLB2016-09-16
00842289100824Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7008MG2016-09-16
00842289100831Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7115MG2016-09-16
00842289100848Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7116MG2016-09-16
00842289100855Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7117MG2016-09-16
00842289100862Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7118MG2016-09-16
00842289101821Medisystems Apheresis Needle Set with MasterGuardMEDISYSTEMS CORPORATIONP9-7017MG2017-10-26
00868465000108Plasma Exchange tubesetASAHI KASEI MEDICAL AMERICA INC.064I2015-09-23
00868465000115Plasma Exchange TubesetASAHI KASEI MEDICAL AMERICA INC.066I2015-09-23
04086000100052AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGL6R23372024-10-30
04086000100090AMICUS Apheresis Kit – Single NeedleFresenius Kabi AGX6R23122025-11-03
04086000100953AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGX6R23012020-06-23
04086000100960AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution ConnectorFresenius Kabi AGX6R23022020-06-23
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally ClosedFresenius Kabi AG4R23672016-09-09
04086000101035ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AG4R57422023-12-13
04086000101370Fenwal AMICUS Single Needle Advanced KitFresenius Kabi AG4R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced KitFresenius Kabi AG4R23542016-09-02
04086000901543TPE Plasma Exchange SetFresenius Kabi AG94004512016-09-16
05020583700314Accessory Platelet Bag with Integrated SamplerTERUMO BCT, INC.700312022-11-23
08888483005321JMS WINGEATER APHERESIS NEEDLE SETJMS SINGAPORE PTE LTD820-5008-332016-09-23
08888483005369JMS WINGEATER APHERESIS NEEDLE SETJMS SINGAPORE PTE LTD820-6019-332016-09-23
08888483005420JMS SYSLOC APHERESIS NEEDLE SETJMS SINGAPORE PTE LTD824-1604-332016-09-23
08888483005444JMS SYSLOC APHERESIS NEEDLE SETJMS SINGAPORE PTE LTD824-1804-332016-09-23
10812747011686Haemonetics® PCS®2, NexSys PCS™ & MCS®+ SystemsHAEMONETICS CORPORATION0625B-002018-02-16
10812747011693Haemonetics® PCS®2, NexSys PCS™ & MCS®+ SystemsHAEMONETICS CORPORATION00690-002018-02-16
10812747011709Haemonetics® PCS®2, NexSys PCS™ & MCS®+ SystemsHAEMONETICS CORPORATION00692-002018-02-16
10812747011716Haemonetics® PCS®2, NexSys PCS® & MCS®+ SystemsHAEMONETICS CORPORATIONSC690-002022-10-26
10812747011730Haemonetics® PCS®2 & NexSys PCS™ SystemsHAEMONETICS CORPORATION00695-002018-02-16
10812747011754Haemonetics® PCS®2 & NexSys PCS™ SystemsHAEMONETICS CORPORATION00620-002018-02-16
10812747011761Haemonetics® PCS®2 & NexSys PCS™ SystemsHAEMONETICS CORPORATION00620-CP2018-02-16
10812747012072HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATION00980-002017-02-08
10812747012089HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATION00981-002017-02-08
10812747012096HAEMONETICS MCS+ APHERESIS SYSTEMHAEMONETICS CORPORATION00994-002017-01-31
10812747012270HAEMONETICS MCS+ (LN9000) SYSTEMHAEMONETICS CORPORATION994CF-CPP2017-02-08
10812747013475HAEMONETICS MCS+ (LN8150) RBC APHERESISHAEMONETICS CORPORATION00822-002017-03-20
10812747013482HAEMONETICS MCS+ (LN8150) for RBC APHERESISHAEMONETICS CORPORATION00832-002017-04-17
10812747013499HAEMONETICS MCS+ (LN8150) RBC APHERESISHAEMONETICS CORPORATION00822-2P2017-03-20
10812747013505HAEMONETICS MCS+ (LN8150) AND RBC APHERISISHAEMONETICS CORPORATION0822F-2P2017-04-17
10812747013512MCS+ (LN8150) RBC APHERESISHAEMONETICS CORPORATION0832F-002017-02-08
10812747019279Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATION00620-CP-CC2024-07-19
10812747019330Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0625Q-002023-06-29
10812747019347Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATION00620-CC2024-07-19
10812747019736Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0625Q-002024-07-17
10812747019859Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION00620-NX2026-03-20
30812747019808Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0699S-122024-10-10
30812747019815Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0699S-152025-07-16
M535CAR510B0NXSTAGE TPE CARTRIDGENXSTAGE MEDICAL, INC.CAR-510-B2015-09-01
M535CAR510C0NXSTAGE TPE CARTRIDGENXSTAGE MEDICAL, INC.CAR-510-C2015-09-01
30812747019853Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION00620-NX2026-03-20
01081002044222Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGX7R2326SB2026-02-03
00812747019814Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0699S-152025-07-16
14086000100059AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGL6R23372024-10-30
00812747019807Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0699S-122024-10-10
30812747019273Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATION00620-CP-CC2024-07-19
30812747019341Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATION00620-CC2024-07-19
30812747019730Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0625Q-002024-07-17
10810020441632Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AG4R23602024-01-24
10810020441649Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AG4R23612024-01-24
14086000101032ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AG4R57422023-12-13
30812747013516MCS+ (LN8150) RBC APHERESISHAEMONETICS CORPORATION0832F-002017-02-08
30812747019334Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATION0625Q-002023-06-29
M535CAR510B5NXSTAGE TPE CARTRIDGENXSTAGE MEDICAL, INC.CAR-510-B2015-09-01
10810020440277AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS SpikeFresenius Kabi AG4R23582023-05-22
10810020440765AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS SpikeFresenius Kabi AG4R23592023-05-22
10810020441113PLASMACELL Xi Disposable Set with SPIKESMARTFresenius Kabi AG6R2600P2023-02-24
35020583700315Accessory Platelet Bag with Integrated SamplerTERUMO BCT, INC.700312022-11-23
30812747011710Haemonetics® PCS®2, NexSys PCS® & MCS®+ SystemsHAEMONETICS CORPORATIONSC690-002022-10-26
04086000101028ALYX Plasma KitFresenius Kabi AG4R57302022-04-28