CHARTER MEDICAL, LTD.

Address:3948-A WEST POINT BLVD.,Winston Salem,NC,27103,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

Microfilter, Blood Transfusion (CAK) (5) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (4) Container, Frozen Donor Tissue Storage (LPZ) (1)

Premarket Exempt

Yes No

Clear

Cell Freeze - 00817827023088 Catalog Number : CML-75LN

Device Description : Cell Freeze Cryogenic Container Fill Range (50-90 mL)

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827024016 Catalog Number : N40-960-00

Device Description : Neonatal/Pediatric Syringe Set 40µ Filter with 30cc Sryinge

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

N/A - 00817827024023 Catalog Number : N40-960-10

Device Description : Neonatal/Pediatric Syringe Set 40µ Filter with 50cc Syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

N/A - 00817827024030 Catalog Number : N40-960-33

Device Description : Neonatal/Pediatric Syringe Set 40µ Filter with Syringe Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

N/A - 00817827024047 Catalog Number : N40-960-35

Device Description : Neonatal/Pediatric Syringe Set 40µ Filter with 35cc Monoject® Syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

N/A - 00817827024054 Catalog Number : N40-960-37

Device Description : Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

N/A - 00817827025013 Catalog Number : T2286

Device Description : 150mL Six Bag Aliquot System With Peircinh Pin and Needless Syringe Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025020 Catalog Number : T8006

Device Description : Pooling Harness Set 6 Lead Harness Set

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025037 Catalog Number : T8010

Device Description : Pooling Harness Set 10 Lead Harness Set

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025044 Catalog Number : C600

Device Description : 600mL Bag with Piercing Pin AUTOLOGOUS TRANSFER SETS

Device Class :

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 12

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