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

Apparatus, Autotransfusion (CAC) (10)

Premarket Exempt

No Yes

Clear

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016537 Catalog Number :

Device Description : CS ELITE PROCESSING KIT (125ML)

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016544 Catalog Number :

Device Description : CS ELITE PROCESSING KIT (225ML)

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016551 Catalog Number :

Device Description : SEQUESTRATION KIT

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016568 Catalog Number :

Device Description : WASTE BAG, 10L

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016575 Catalog Number :

Device Description : CS ELITE FASTPACK,125ML,150µ

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016582 Catalog Number :

Device Description : CS ELITE FASTPACK,225ML,150µ

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER ELITE SYSTEM - 10812747016636 Catalog Number :

Device Description : CS ELITE FASTPACK, 225ML, 20µ

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS ORTHOPAT & CARDIOPAT SYSTEMS - 10812747017022 Catalog Number :

Device Description : 400 ML RBC BAG

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS ORTHOPAT & CARDIOPAT SYSTEMS - 10812747017039 Catalog Number :

Device Description : 3 LITER WASTE BAG

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS ORTHOPAT SYSTEM - 10812747017046 Catalog Number :

Device Description : ORTHOPAT POST-OP LINE

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

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