Haemonetics

Primary DI
30887691306373
Brand
Haemonetics
Company
HAEMONETICS CORPORATION
Model
400-03
Device description
Bacerial Detection System for Quality Control Testing of Platelet Products
Published
2017-03-20
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
MZCSystem,detection,bacterial, for platelet transfusion products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZCSystem, Detection, Bacterial, For Platelet Transfusion ProductsMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0700630

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700630

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30887691306373PackageGS110In Commercial Distribution
20887691306376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088769130637330887691306373
2088769130637620887691306376

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
00382904420536BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
00382904420543BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420537BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420544BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
10850046056069Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056076Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056083Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056090Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056021Platelet PGDprime Reagent 1BVerax Biomedical IncorporatedMZC2023-04-19
10850046056250Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056243Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056236Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056113Platelet PGDprime Test, 20 devices plus disposablesVerax Biomedical IncorporatedMZC2023-04-19
10850046056120Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056137Platelet PGDprime Reagents, 100 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056144Platelet PGDprime Reagents, 20 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056007Platelet PGDprime TestVerax Biomedical IncorporatedMZC2023-04-17
10850046056014Platelet PGDprime Reagent 1AVerax Biomedical IncorporatedMZC2023-04-13
10850046056038Platelet PGDprime Reagent 2Verax Biomedical IncorporatedMZC2023-04-13
03573026612047BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-06-26
03573026614157BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-06-26
03573026614140BACT/ALERT®BIOMERIEUX , INC.MZC2020-06-26
03573026611323BACT/ALERT®BIOMERIEUX , INC.MZC2020-06-26
03573026595975BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
03573026595999BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-04-27
03573026126742BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
03573026126735BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-04-27
20887691306376HaemoneticsHAEMONETICS CORPORATIONMZC2017-03-20