FDA.reportPublic FDA data

ACP 215

Primary DI
30812747015183
Brand
ACP 215
Company
HAEMONETICS CORPORATION
Model
50042-00
Device description
UNIT PACK ASSY,SHAKER,ACP215
Published
2017-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSWSystem, Processing For Frozen BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0600080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30812747015183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081274701518330812747015183

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell freeze/thaw systemAn assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057827420
Device count
1
Serial number
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
10812747015004HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
10812747015011HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
10812747015028HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015008HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015015HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015022HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015800ACP 215HAEMONETICS CORPORATIONKSW2017-01-31
30812747015817ACP 215HAEMONETICS CORPORATIONKSW2017-01-31
00085412010717NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412010724NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412010748NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412081908NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412081915NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
50085412010712NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412010729NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412010743NABAXTER INTERNATIONAL INC.KSW2016-09-24
60085412081900NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412081910NABAXTER INTERNATIONAL INC.KSW2016-09-24
04086000101271Glycerolyte 57 SolutionFresenius Kabi AGKSW2016-09-02
04086000101288Glycerolyte 57 SolutionFresenius Kabi AGKSW2016-09-02