HAEMONETICS CORPORATION

Address:549 Aldi Blvd,Mount Juliet,TN,37122,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) (4) SYSTEM, PROCESSING FOR FROZEN BLOOD (KSW) (3) Apparatus, Autotransfusion (CAC) (2) APPARATUS, AUTOTRANSFUSION (CAC) (1)

Premarket Exempt

No Yes

Clear

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 30812747012854 Catalog Number :

Device Description : MCS+, 220V ENGL, LN 09000-220-E

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 30812747012878 Catalog Number :

Device Description : MCS+, 220V, LN09000-220-EW-RU

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

MCS+ - 30812747013851 Catalog Number :

Device Description : MCS+ (RBC), LIST NO 08150-220-E

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

MCS+ - 30812747013875 Catalog Number :

Device Description : MCS+ (RBC), LIST NO 08150-110-E

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

ACP 215 - 30812747015183 Catalog Number :

Device Description : UNIT PACK ASSY,SHAKER,ACP215

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

ACP 215 - 30812747015800 Catalog Number :

Device Description : ACP215, 110V, LN 02215-110-E

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

ACP 215 - 30812747015817 Catalog Number :

Device Description : ACP215, 220V, LN 02215-220-E

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : KSW

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE+ SYSTEM - 30812747016364 Catalog Number :

Device Description : CELL SAVER ELITE+

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 30812747016616 Catalog Number :

Device Description : CELL SAVER ELITE

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER 5+ SYSTEM - 30812747016814 Catalog Number :

Device Description : CS5+,110V ENG, LN02005-110-EP

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

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