CHARTER MEDICAL, LTD.

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

Set, Transfer (Blood/Plasma) (KSB) (6) System, Suspension, Cell Culture (KJF) (4)

Premarket Exempt

Yes No

Clear

Advect™ - 00817827026164 Catalog Number : CT-014-XL

Device Description : Fluid Transfer Sets 5mL Syringe with PVC Lead and Spike Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect - 00817827026171 Catalog Number : CT-018-08

Device Description : Fluid Transfer Sets 8 Lead Harness with Port Adapter (6" L)

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect - 00817827026188 Catalog Number : CT-018-10

Device Description : Fluid Transfer Sets 10 Lead Harness with Port Adapter (6" L)

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect - 00817827026195 Catalog Number : CT-018-50

Device Description : Fluid Transfer Sets 6" PVC - Spike with Female Luer and Twist off

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect - 00817827026201 Catalog Number : CT-018-90

Device Description : Fluid Transfer Sets 6" PVC with Spike Adapter and Luer

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect - 00817827026218 Catalog Number : CT-018-94

Device Description : Fluid Transfer Sets 6" PVC with Spike and Male Luer

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

EXP-PAK - 00817827027017 Catalog Number : EXP-1L

Device Description : EXP-PAK Cell Expansion Container 1L Capacity

Device Class : 1

Duns Number: 029062325

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

EXP-PAK - 00817827027024 Catalog Number : EXP-3L

Device Description : EXP-Pak Cell Expansion Container 3L Capacity

Device Class : 1

Duns Number: 029062325

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

EXP-PAK - 00817827027031 Catalog Number : EXP-5L

Device Description : EXK-Pak Cell Expansion Container 5L Capacity

Device Class : 1

Duns Number: 029062325

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

EXP-PAK - 00817827027048 Catalog Number : EXP-500

Device Description : EXP-PAK Cell Expansion Container 500 mL Capacity

Device Class : 1

Duns Number: 029062325

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

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