FDA.reportPublic FDA data

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM

Primary DI
10812747012072
Brand
HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM
Company
HAEMONETICS CORPORATION
Model
00980-00
Device description
TPE Disposable,225mLLathamBwl
Published
2017-02-08
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
LKNSEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953681000HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SETHaemonetics Corp.1996-06-04LKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30812747012076PackageGS18In Commercial Distribution
10812747012072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081274701207630812747012076
1081274701207210812747012072

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 Volume225Milliliter

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
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2024-03-27
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2023-05-24
00810020441208AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2023-05-23
05020583707009COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
05020583909014COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909045COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909120COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583707000COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
35020583909015COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909046COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909121COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583102200Spectra Optia® TERUMO BCT, INC.LKN2021-05-05
00810020440218AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440249AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440171AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2020-11-18
00810020440232AMICUS SeparatorFresenius Kabi AGLKN2020-10-20
04086000101912AMICUS Separator SoftwareFresenius Kabi AGLKN2020-01-21
04052682031717Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2019-02-20
04052682031724Waste Transfer SetFresenius Kabi AGLKN2019-02-20
04086000101950AMICUS Exchange Kit - TherapeuticsFresenius Kabi AGLKN2019-02-20
10812747012089HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATIONLKN2017-02-08
04086000901543TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
04052682003721P1R Plasma Treatment SetFresenius Kabi AGLKN2016-09-16
04086000860154COM.TECFresenius Kabi AGLKN2016-09-16
04086000901550TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
05020583103108Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
05020583610002Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
04086000100151AMICUS Exchange KitFresenius Kabi AGLKN2016-09-05
04086000100168Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2016-09-05