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) (8) APPARATUS, AUTOTRANSFUSION (CAC) (2)

Premarket Exempt

No Yes

Clear

HAEMONETICS CELL SAVER SYSTEMS - 10812747016001 Catalog Number :

Device Description : RBC BAG WITH LUER LOCK, 600ML

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEMS - 10812747016018 Catalog Number :

Device Description : WASTE BAG, 5L

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEM - 10812747016025 Catalog Number :

Device Description : Y CONNECTOR WITH CHECK VALVE

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEM - 10812747016032 Catalog Number :

Device Description : RESERVOIR,HARDSHELL,150 µ_ Note: Additional packaging DI: 20812747016039, Unit P RESERVOIR,HARDSHELL,150 µ_ Note: Additional packaging DI: 20812747016039, Unit Packaging, contains (1) 10812747016032 DI:30812747016036, carton contains (4) 20812747016039

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEM - 10812747016049 Catalog Number :

Device Description : ASPIRATION/ANTICOAGULATION SET

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEM - 10812747016063 Catalog Number :

Device Description : RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packag RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (1) 1082747016063

Device Class :

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEM - 10812747016070 Catalog Number :

Device Description : Y SET WITH EXTENSION LINE

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER SYSTEMS - 10812747016094 Catalog Number :

Device Description : RBC BAG W/TWIST LOCK, 1000ML

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016100 Catalog Number :

Device Description : 10 LITER WASTE BAG

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016117 Catalog Number :

Device Description : CS5/5+ FASTPACK, 225ML 150U RES

Device Class : 2

Duns Number: 057827420

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

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