FDA.reportPublic FDA data

Cardioplegia Plus

Primary DI
30887691000301
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057827420
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10887691000307Cardioplegia 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