HAEMONETICS CORPORATION

Address:1300 Clifford Ball Drive,Clinton,PA,15026,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Separator, automated, blood cell, diagnostic (GKT) (5) SYSTEM, PROCESSING FOR FROZEN BLOOD (KSW) (3) Apparatus, Autotransfusion (CAC) (2)

Premarket Exempt

No Yes

Clear

HAEMONETICS MCS+ (LN8150) RBC APHERESIS - 10812747013475 Catalog Number :

Device Description : REDCELLS & PLASMA DISPOSABLESET

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN8150) for RBC APHERESIS - 10812747013482 Catalog Number :

Device Description : TWO UNIT RED CELLS DISPOSABLE SETS

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN8150) RBC APHERESIS - 10812747013499 Catalog Number :

Device Description : REDCELLS & PLASMA DISPOSABLESET

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN8150) AND RBC APHERISIS - 10812747013505 Catalog Number :

Device Description : RBCF-2P SET

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

MCS+ (LN8150) RBC APHERESIS - 10812747013512 Catalog Number :

Device Description : 2 UNIT RED CELL SET W/RC2H FIL

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS ACP 215 SYSTEM - 10812747015004 Catalog Number :

Device Description : RBC GLYCEROLIZATION SET

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

HAEMONETICS ACP 215 SYSTEM - 10812747015011 Catalog Number :

Device Description : RBC DE-GLYCEROL./CELL WASH SET

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

HAEMONETICS ACP 215 SYSTEM - 10812747015028 Catalog Number :

Device Description : RBC DE-GLYCEROL. SET 325ML BMB

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747015165 Catalog Number :

Device Description : HIGH SPEED CELL SAVER5/5+BOWL SET

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747015172 Catalog Number :

Device Description : CELL SAVER 5/5+ BOWL SET (70ML)

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

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