FDA.reportPublic FDA data

Cardioplegia Plus

Primary DI
10887691000307
Brand
Cardioplegia Plus
Company
HAEMONETICS CORPORATION
Model
CPS02
Device description
Filters with Solution Spike
Published
2017-01-19
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
JODFILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875095000PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.1988-02-29JOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30887691000301PackageGS140In Commercial Distribution
10887691000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088769100030130887691000301
1088769100030710887691000307

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, single-packAn 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.

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
No natural rubber latex
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
04058863019222QUADROX-iMaquet Cardiopulmonary AGJOD2017-10-12
04037691838663VHK Venous ReservoirMaquet Cardiopulmonary AGJOD2017-03-13
04037691854984VHK reservoir AdMaquet Cardiopulmonary AGJOD2017-03-13
04058863007403QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-16
04058863018843QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-16
04058863005805QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-15
04058863018867QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-15
30887691000301Cardioplegia PlusHAEMONETICS CORPORATIONJOD2017-01-19
04037692010006QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692009987QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692009994QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692011362QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692010013QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037691833545NAMaquet Cardiopulmonary AGJOD2015-10-24
04037691906942QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691913032QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691965307QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691965628QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24