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

Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (5) Set, Transfer (Blood/Plasma) (KSB) (5)

Premarket Exempt

Yes No

Clear

N/A - 00817827025259 Catalog Number : T4005

Device Description : 400mL Transfer Bag with 5 Lead Harness Set

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025266 Catalog Number : T4006

Device Description : Pooling Harness Set 6 Lead Pooling Bag 400mL

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025273 Catalog Number : T4105

Device Description : 400mL Transfer Bag with 5-Lead Tubing Assembly

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025280 Catalog Number : T6010

Device Description : Pooling Harness Set 10 Lead Pooling Bag, 600mL Bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

N/A - 00817827025297 Catalog Number : T8703H

Device Description : Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Nee Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Advect™ - 00817827026010 Catalog Number : CT-014-00

Device Description : Fluid Transfer Sets 24" PVC with 2 Spike Adapters

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect™ - 00817827026027 Catalog Number : CT-014-06

Device Description : Fluid Transfer Sets 6 Lead Harness with Port Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect™ - 00817827026034 Catalog Number : CT-014-08

Device Description : Fluid Transfer Sets 8 Lead Harness with Port Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect™ - 00817827026041 Catalog Number : CT-014-10

Device Description : Fluid Transfer Sets 10 Lead Harness with Port Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Advect™ - 00817827026058 Catalog Number : CT-014-50

Device Description : Fluid Transfer Sets 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

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