FDA.reportPublic FDA data

HAEMONETICS MCS+ (LN8150) for RBC APHERESIS

Primary DI
10812747013482
Brand
HAEMONETICS MCS+ (LN8150) for RBC APHERESIS
Company
HAEMONETICS CORPORATION
Model
00832-00
Device description
TWO UNIT RED CELLS DISPOSABLE SETS
Published
2017-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKTSeparator, automated, blood cell, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKTSeparator, Automated, Blood Cell, DiagnosticHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0500480

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500480

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30812747013486PackageGS120In Commercial Distribution
10812747013482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081274701348630812747013486
1081274701348210812747013482

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system tubing setA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume275Milliliter
Total Volume600Milliliter
Total Volume1000Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(800)-537-2802pirdesk@Haemonetics.com

Regulatory Flags#

DUNS number
057827420
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812747018203TEG500007-0442017-05-30
10812747018210TEG500007-0452017-05-30
10812747018296TEG6s HEMOSTASIS SYSTEM07-650-US2017-07-17
10812747018302TEG6s HEMOSTASIS SYSTEM07-651-US2017-08-18
10812747018326TEG6s HEMOSTASIS SYSTEM07-601-US2017-04-25
10812747018340TEG6S HEMOSTASIS SYSTEM07-662US2017-07-17
10812747018463Hemostasis System07-605-US2021-06-17
10812747018531Global Hemostasis - HN07-604-US2024-04-10
20812747018491Haemonetics TEG 6s07-664-US2021-06-17
20812747018514Haemonetics TEG 6s07-665US2021-06-18
20812747018002TEG5000 HEMOSTASIS SYSTEM07-0042017-06-16
20812747018019TEG5000 HEMOSTASIS SYSTEM07-0062017-06-16
20812747018026TEG5000 HEMOSTASIS SYSTEM07-0072017-06-16
20812747018033TEG5000 HEMOSTASIS SYSTEM07-0082017-06-16
10812747019859Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747019853Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747011659HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEMPCS-300-US2017-11-01
10887691000116HaemoneticsPL1B2016-12-15
10887691000161Haemonetics EZ PrimeRCEZ1T2016-12-15
10887691000178HaemoneticsRCEZKS2022-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10812747019859Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
30812747019853Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
00811137013104Amicus SeparatorFresenius Kabi AGGKT2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
04086000100090AMICUS Apheresis Kit – Single NeedleFresenius Kabi AGGKT2025-11-03
00810020440560Aurora XiFresenius Kabi AGGKT2025-02-26
00810020442199Aurora XiFresenius Kabi AGGKT2025-02-26
04086000100052AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
14086000100059AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
10812747019279Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019347Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019273Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019341Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019736Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
30812747019730Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGGKT2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGGKT2024-03-27
00810020441635Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
00810020441642Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441632Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441649Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
04086000101035ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
14086000101032ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
10812747019330Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
30812747019334Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
05020583826502Trima AccelTERUMO BCT, INC.GKT2023-06-19
35020583826503Trima AccelTERUMO BCT, INC.GKT2023-06-19
05020583910003COBE® 2991 TERUMO BCT, INC.GKT2023-06-19
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AGGKT2023-05-24