HAEMONETICS CORPORATION

Address:549 Aldi Blvd,Mount Juliet,TN,37122,US

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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) (8) SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC (LKN) (2)

Premarket Exempt

No Yes

Clear

Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011709 Catalog Number :

Device Description : PLS Bag w/NaCl Spike

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Haemonetics® PCS®2 & NexSys PCS™ Systems - 10812747011730 Catalog Number :

Device Description : PLS Saline Adaptor

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Haemonetics® PCS®2 & NexSys PCS™ Systems - 10812747011754 Catalog Number :

Device Description : PLS Harness Set

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Haemonetics® PCS®2 & NexSys PCS™ Systems - 10812747011761 Catalog Number :

Device Description : PLS Harness Set

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 10812747012072 Catalog Number :

Device Description : TPE Disposable,225mLLathamBwl

Device Class : U

Duns Number: 057827420

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 10812747012089 Catalog Number :

Device Description : TPE Disposable,125mLLathamBwl

Device Class : U

Duns Number: 057827420

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ APHERESIS SYSTEM - 10812747012096 Catalog Number :

Device Description : MCS+ SDP/PLP W/SALINE,LN 994

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

HAEMONETICS MCS+ (LN9000) SYSTEM - 10812747012270 Catalog Number :

Device Description : MCS+ SDP/PLP CON FIL,994CF-CPP

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

MCS+ - 10812747012485 Catalog Number :

Device Description : SDP/PLP PROT MANUL,LN 09081-00

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

MCS+ - 10812747012492 Catalog Number :

Device Description : TPE PROTOCOL/MANUAL,LN09082-00

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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