FDA.reportPublic FDA data

HAEMONETICS ACP 215 SYSTEM

Primary DI
30812747015022
Brand
HAEMONETICS ACP 215 SYSTEM
Company
HAEMONETICS CORPORATION
Model
00236-00
Device description
RBC DE-GLYCEROL. SET 325ML BMB
Published
2017-02-07
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
KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0300620

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0300620

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30812747015022PackageGS120In Commercial Distribution
10812747015028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081274701502230812747015022
1081274701502810812747015028

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell freeze/thaw system setA sterile collection of devices intended to be used in a blood cell processing system to either prepare red blood cells for frozen storage (glycerolization), or deglycerolize and wash red blood cells after thawing (may also wash fresh red blood cells). The device typically consists of a bacteriological filter, solution lines, connection ports, and collection containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Liter
Total Volume325Milliliter
Total Volume600Milliliter

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
30812747015183ACP 215HAEMONETICS CORPORATIONKSW2017-05-02
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
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