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

Blood Establishment Computer Software and Accessories (MMH) (5) Medical device data system (OUG) (2) Separator, automated, blood cell, diagnostic (GKT) (2) SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS (MMH) (1)

Premarket Exempt

No Yes

Clear

ElDorado Donor - 00812747010149 Catalog Number :

Device Description : ElDorado Donor version 3.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

TEG Manager - 00812747010156 Catalog Number :

Device Description : TEG Manager 4.x.x

Device Class : 1

Duns Number: 057827420

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

TEG Manager - 00812747010163 Catalog Number :

Device Description : TEG Manager 1.x.x

Device Class : 1

Duns Number: 057827420

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Surround - 00812747010170 Catalog Number :

Device Description : Surround version 5.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

NexLynk DMS - 00812747010187 Catalog Number :

Device Description : NexLynk DMS version 4.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Symphony - 00812747010194 Catalog Number :

Device Description : Symphony version 3.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Donor Doc - 00812747010200 Catalog Number :

Device Description : Donor Doc version 3.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

NDDR (National Donor Deferral Registry) - 00812747010217 Catalog Number :

Device Description : NDDR version 2.x.x

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011686 Catalog Number :

Device Description : BMB PLS Bowls

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011693 Catalog Number :

Device Description : PLS Bag

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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